Plasma citrulline levels as a biomarker for bowel toxicity in prostate stereotactic radiotherapy with or without pelvic nodal radiation.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 73-73
Author(s):  
Ciaran Fairmichael ◽  
Kelly M. Redmond ◽  
Ciara Lyons ◽  
Sarah R. Stevenson ◽  
Sarah O. Osman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Small Bowel ◽  
Stereotactic Radiotherapy ◽  
Summary Score ◽  
Pelvic Radiotherapy ◽  
Exact Test ◽  
Plasma Citrulline ◽  
Patient Reported ◽  
To Receive

73 Background: Plasma levels of citrulline, an amino acid, are derived mainly from small bowel enterocytes. Decreased levels occur in a range of bowel conditions and citrulline has been proposed as a biomarker of bowel toxicity in pelvic radiotherapy. In a prospective study, we identify no correlation between plasma citrulline and toxicity in men receiving prostate stereotactic radiotherapy randomized to receive either pelvic nodal irradiation or not. Furthermore, citrulline levels were not significantly different between these two groups. Methods: As part of an approved clinical trial, men with intermediate to high risk prostate cancer were randomised 1:1 to prostate only or prostate + pelvic nodal radiotherapy, delivered with a rectal spacer gel in situ. The prostate and proximal seminal vesicles received 40 Gy in 5 fractions. Those randomised to the pelvic nodal arm also received 25 Gy in 5 fractions to pelvic nodes. Citrulline was measured at 10 points during treatment – consent, before fraction 1, 1 and 24 hours following fraction 1, prior to each fraction 2 – 5 and at 6 weeks’ and 3 months’ follow up. Bowel toxicity was measured by EPIC patient reported scores. Results: 16 men with follow up of at least 3 months (median 9, maximum 18 months) were analysed. Reported toxicity was significantly higher in the prostate and pelvis arm: 5 of 9 men showed a decrease in EPIC bowel domain summary score of 10 points or more compared to 0 of 7 in the prostate-only arm (p = 0.0337, two tailed Fisher’s exact test). No significant correlation between toxicity and citrulline levels was seen, nor did citrulline vary significantly between arms or fall as treatment progressed. Data analysis for a further 8 men already recruited to the study is ongoing. Conclusions: Toxicity was more commonly reported by men randomised to receive pelvic radiotherapy, suggesting that the small bowel irradiated in pelvic fields plays a role in bowel toxicity experienced during stereotactic radiotherapy. Citrulline levels showed no significant correlation with toxicity or radiation dose to small bowel. We propose that citrulline is not a useful biomarker of small bowel toxicity in this setting. Clinical trial information: NCT03253978.

Implementing Digital Technology to Transitioning a Clinical Trial to a Registry – TAILOR-PCI Digital Study: Methods/Study Design (Preprint)

2021 ◽  
Author(s):  
Robert Avram ◽  
Derek So ◽  
Erin Iturriaga ◽  
Julia Byrne ◽  
Ryan Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Completion Rate ◽  
Phone Call ◽  
Consent Rate ◽  
Digital Platform ◽  
Phone Calls ◽  
Patient Reported ◽  
Research Platform

BACKGROUND TAILOR-PCI was the largest cardiovascular genotype-based randomized clinical trial (RCT) investigating whether CYP2C19 genotype-guided selection of oral P2Y12 inhibitor therapy improved ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Registry was a novel proof-of-concept study that evaluated the feasibility of extending the main RCT follow-up period using a remote digital platform. OBJECTIVE To describe patients onboarding, engagement and results of a digital registry after enrollment in a RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letters containing a URL to the TAILOR-PCI Digital Registry website (http://tailorpci.eurekaplatform.org), instructing them to download the study app. Patients previously enrolled in the TAILOR-PCI study, with a smartphone, were eligible to join the Digital Registry. Those who did not respond to the letter were contacted by phone to survey reasons for non-participation and were invited again to join the study. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard, consent and enrol patients in the Digital Registry. Patients were asked to complete health-related surveys and provide follow-up data digitally. Consent rate to the Digital Registry, duration of participation in the Digital Registry and monthly activity completion rate. The hypothesis being tested was formulated before data collection began. RESULTS After the parent trial was completed, letters were mailed to 907 eligible patients (representing 19% of total enrolled in the RCT) across 24 sites, who were within 15.6 ± 5.2 months after randomization leading to 290 unique individuals visits to the Digital Registry website. Among those invited, 110 patients (12%) consented: 45 (41%) after the letter, 37 (34%) after the 1st phone call and 28 (25%) after a 2nd call. Of the 862 who didn’t consent after the letter, 453 patients (53%) did not respond to repeated phone calls and among the 409 patients who responded, 171 (41%) declined participation stating lack of time, 128 (31%), due to lack of smartphone and 47 (11%) due to difficulty understanding what was expected of them in the study. Patients who consented were older, had less diabetes or tobacco use; a greater proportion had bachelor's degrees or higher and were more computer literate than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9±7.6% without a decrease in this rate throughout the study duration. There were no differences between randomization arms in any patient reported outcomes using the digital platform. CONCLUSIONS Extended follow-up after enrollment in a RCT using a digital registry is technically feasible but was limited due to inability to contact most eligible patients, lack of time or access to a smartphone. Among those enrolled, most patients completed required electronic visits. Enhanced recruitment methods, such as introduction of the digital study at the time of RCT consent, provision of smartphone and robust study support for onboarding, should be explored further. CLINICALTRIAL TAILOR-PCI (Clinicaltrials.gov: NCT01742117)

scholarly journals Patient-Reported Outcome (PRO) as an Addition to Long-Term Results after High-Precision Stereotactic Radiotherapy in Patients with Secreting and Non-Secreting Pituitary Adenomas: A Retrospective Cohort Study up to 17-Years Follow-Up

Cancers ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 1884
Author(s):  
Kerstin A. Kessel ◽  
Christian D. Diehl ◽  
Markus Oechsner ◽  
Bernhard Meyer ◽  
Jens Gempt ◽  
...  
Keyword(s):  
High Precision ◽  
Stereotactic Radiotherapy ◽  
Pituitary Adenomas ◽  
Patient Reported Outcome ◽  
Long Term Results ◽  
Effective Treatment Option ◽  
Patient Reported ◽  
Precision Radiotherapy ◽  
High Precision Radiotherapy

High-precision radiotherapy has been established as a valid and effective treatment option in patients with pituitary adenomas. We report on outcome after fractionated stereotactic radiotherapy (FSRT) in correlation with patient-reported outcomes (PROs). We analyzed 69 patients treated between 2000 and 2019. FSRT was delivered with a median total dose of 54 Gy (single fraction: 1.8 Gy). PRO questionnaires were sent to 28 patients. Median overall survival was 17.2 years; mean local control was 15.6 years (median not reached). Median follow-up was 5.8 years. Twenty (71%) patients participated in the PRO assessment. Physicians reported symptoms grade ≥3 in 6 cases (9%). Of all, 35 (51%) patients suffered from hypopituitarism at baseline, and during follow-up, new or progressive hypopituitarism was observed in 11 cases (16%). Patients reported 10 cases of severe side effects. Most of these symptoms were already graded as CTCAE (Common Terminology Criteria for Adverse Events) grade 2 by a physician in a previous follow-up exam. PROs are an essential measure and only correlate to a certain extent with the physician-reported outcomes. For high-precision radiotherapy of pituitary adenomas, they confirm excellent overall outcomes and low toxicity. In the future, the integration of PROs paired with high-end treatment will further improve outcomes.

Results of the ADRRAD Trial of pelvic IMRT plus radium-223 in men with mHSPC metastatic to bone.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 136-136
Author(s):  
Joe O'Sullivan ◽  
Philip Geoffrey Turner ◽  
Suneil Jain ◽  
Arthur Grey ◽  
Sandra Biggart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Phase 1 ◽  
Palliative Radiotherapy ◽  
Progression Free Survival ◽  
Castration Resistant Prostate Cancer ◽  
Pelvic Radiotherapy ◽  
Serious Adverse Events ◽  
Radium 223

136 Background: Radiotherapy to the Prostate in mHSPC improves overall survival (OS) and Progression free survival (PFS) for patients with low-volume-disease[1]. Radium-223 in metastatic castration resistant prostate cancer (mCRPC) improves OS [2]. We conducted a prospective phase 1/2 clinical trial in mHSPC, testing the combination of with LHRHa, concurrent pelvic radiotherapy and radium-223. Methods: Thirty patients were recruited with mHSPC; they had a minimum of 3 bone metastases (majority had > 20 bone mets), nil visceral metastases, PS0-1. Patients were encouraged to receive up front docetaxel. They were treated with ongoing LHRHa, pelvic radiotherapy aiming for 74Gy in 37 fractions to prostate PTV with 60Gy concomitantly delivered to pelvic nodal PTV. Concurrently, patients received radium-223, 55kBq/kg for 6 cycles q28 days; fraction 1 radiotherapy was synchronous with cycle 1 day 1 radium-223. Results: Median age was 63 years and 28 (93%) received at least 4 cycles of docetaxel. One patient received prostate only radiotherapy due to bowel constraints. Three patients had cycle 6 radium-223 omitted. At a median follow-up of 28 months, there have been 415 Adverse events, (3% Grade >3), and 6 serious adverse events (SAEs) ( 2 episodes of UTI, 1 each of cystitis non-infective, cardiac chest pain, pyrexia and AKI). Commonest AEs by number were: leucopenia, neutropenia, and diarrhoea. Ten SSE’s have occurred including 8 courses of palliative radiotherapy for bone pain, 1 course of radiotherapy for impending MSCC and 1 pathological fracture. At median follow up 28.0 months, median biochemical PFS is 17.9 months, median OS not yet reached. Conclusions: This trial shows clear tolerability and promising early efficacy data requiring further exploration in a randomised phase 3 trial. Clinical trial information: 2014-000273-39.

Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study

2016 ◽  
Vol 76 (4) ◽  
pp. 666-672 ◽  
Author(s):  
Mads Ammitzbøll-Danielsen ◽  
Mikkel Østergaard ◽  
Viktoria Fana ◽  
Daniel Glinatsi ◽  
Uffe Møller Døhn ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Isotonic Saline ◽  
Group Versus ◽  
Controlled Study ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Patient Reported ◽  
Registration Number

ObjectiveThe aim of this study was to compare the efficacy of intramuscular versus ultrasound (US)-guided intratenosynovial glucocorticoid injection in providing disease control after 2, 4 and 12 weeks in patients with rheumatoid arthritis(RA) with tenosynovitis.MethodsFifty patients with RA and tenosynovitis were randomised into two double-blind groups: (A) ‘intramuscular group’, receiving intramuscular injection of betamethasone and US-guided intratenosynovial isotonic saline injection and (B) ‘intratenosynovial group’ receiving saline intramuscularly and US-guided intratenosynovial betamethasone injection. All patients were in stable disease-modifying anti-rheumatic drug treatment prior to and during the study. Patients were excluded, and considered non-responders, if any treatments were altered during the follow-up period. ‘US tenosynovitis remission’, defined as US tenosynovitis grey-scale score ≤1 and colour Doppler score=0, was assessed at week 4 (primary outcome), and weeks 2 and 12, using non-responder imputation for missing data.ResultsUS tenosynovitis remission at week 4 was achieved in 25% (6/24) in the ‘intramuscular group’ versus 64% (16/25) in the ‘intratenosynovial group’, that is, a difference of −39 percentage point (pp) (CI −65pp to −13pp), Fisher exact test p=0.001. Corresponding values for the ‘intramuscular group’ versus the ‘intratenosynovial group’ at 2 and 12 weeks were 21% (5/24) versus 48% (13/25), that is, a difference of −27pp (CI −53pp to −2pp), p=0.072 and 8% (2/24) versus 44% (11/25), that is, difference of −36pp (−58pp to −13pp), p=0.003. Most US, clinical and patient-reported scores improved more in the ‘intratenosynovial group’ at all follow-up visits.ConclusionsIn this randomised double-blind clinical trial, patients with RA and tenosynovitis responded significantly better to US-guided intratenosynovial glucocorticoid injection than to intramuscular glucocorticoid injection, both at 4 and 12 weeks follow-up.Trial registration numberEudraCT nr: 2013-003486-34.

scholarly journals TMPRSS2:ERG Gene Fusion Predicts Subsequent Detection of Prostate Cancer in Patients With High-Grade Prostatic Intraepithelial Neoplasia

2014 ◽  
Vol 32 (3) ◽  
pp. 206-211 ◽  
Author(s):  
Kyung Park ◽  
James T. Dalton ◽  
Ramesh Narayanan ◽  
Christopher E. Barbieri ◽  
Michael L. Hancock ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Gene Fusion ◽  
Intraepithelial Neoplasia ◽  
Prostatic Intraepithelial Neoplasia ◽  
Phase Iii ◽  
High Grade ◽  
Exact Test ◽  
Improve Risk Stratification

Purpose High-grade prostatic intraepithelial neoplasia (HGPIN) is considered a precursor lesion of prostate cancer (PCa). The predictive value of ERG gene fusion in HGPIN for PCa was interrogated as a post hoc analysis in the context of a randomized clinical trial. Patients and Methods The GTx Protocol G300104 randomly assigned 1,590 men with biopsy-diagnosed HGPIN to receive toremifene or placebo for 3 years or until a diagnosis of PCa was made on prostate biopsy. As part of this phase III clinical trial, a central pathologist evaluated biopsies of patients with isolated HGPIN at baseline and 12, 24, and 36 months of follow-up. ERG immunohistochemistry was performed on biopsies from 461 patients and evaluated for protein overexpression. Results ERG expression was detected in 11.1% of patients (51 of 461 patients) with isolated HGPIN. In the first year and during the 3-year clinical trial, 14.7% and 36.9% of 461 patients were diagnosed with PCa, respectively. Patients with ERG expression were more likely to develop PCa, with 27 (53%) of 51 ERG-positive and 143 (35%) of 410 ERG-negative patients experiencing progression to PCa (P = .014, Fisher's exact test). ERG expression was not associated with age, baseline PSA, Gleason score, or tumor volume. Conclusion This study underscores the necessity of more stringent follow-up for men with HGPIN that is also positive for ERG overexpression. Clinicians should consider molecular characterization of HGPIN as a means to improve risk stratification.

scholarly journals The Application of Magnetic-Controlled Capsule Gastroscopy in Patients Refusing C-EGD: A Single-Center 5-Year Observational Study

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Lihan Zhou ◽  
Sijia Wang ◽  
Jian Li ◽  
Jie Zhong ◽  
Ling Zhang ◽  
...  
Keyword(s):  
Small Bowel ◽  
Detection Rate ◽  
Diagnostic Yield ◽  
Lesion Detection ◽  
Gastric Ulcers ◽  
Focal Lesion ◽  
Detection Rates ◽  
Matched Group ◽  
Patient Reported

Background and Aims. Screening for gastric diseases in symptomatic outpatients with conventional esophagogastroduodenoscopy (C-EGD) is expensive and has poor compliance. We aimed to explore the efficiency and safety of magnetic-controlled capsule gastroscopy (MCCG) in symptomatic outpatients who refused C-EGD. Methods. We performed a retrospective study of 76794 consecutive symptomatic outpatients from January 2014 to October 2019. A total of 2318 adults ( F / M = 1064 / 1254 ) in the MCCG group who refused C-EGD were matched with adults in the C-EGD group using propensity-score matching (PSM). The detection rates of abnormalities were analyzed to explore the application of MCCG in symptomatic patients. Results. Our study demonstrated a prevalence of gastric ulcers (GUs) in patients with functional dyspepsia- (FD-) like symptoms of 8.14%. The detection rate of esophagitis and Barrett’s esophagus was higher in patients with typical gastroesophageal reflux disease (GERD) symptoms than in patients in the other four groups ( P < 0.01 ). The detection rates of gastric ulcers in the five groups (abdominal pain, bloating, heartburn, follow-up, and bleeding) were significantly different ( P = 0.015 ). The total detection rate of gastric ulcers in symptomatic patients was 9.7%. A total of 7 advanced carcinomas were detected by MCCG and confirmed by endoscopic or surgical biopsy. The advanced gastric cancer detection rate was not significantly different between the MCCG group and the C-EGD matched group in terms of nonhematemesis GI bleeding (2 vs. 2, P = 1.00 ). In addition, the overall focal lesion detection rate in the MCCG group was superior to that in the C-EGD matched group (224 vs. 184, P = 0.038 ). MCCG gained a clinically meaningful small bowel diagnostic yield of 54.8% (17/31) out of 31 cases of suspected small bowel bleeding. No patient reported capsule retention at the two-week follow-up. Conclusion. MCCG is well tolerated, safe, and technically feasible and has a considerable diagnostic yield. The overall gastric diagnostic yield of gastric focal lesions with MCCG was comparable to that with C-EGD. MCCG offered a supplementary diagnosis in patients who had a previously undiagnostic C-EGD, indicating that MCCG could play an important role in the routine monitoring and follow-up of outpatient. MCCG shows its safety and efficiency in symptomatic outpatient applications.

scholarly journals Effect of Balloon Eustachian Tuboplasty in Adults That Only Have Symptoms of Chronic Eustachian Tube Dysfunction, With a 1-Year Follow-Up: Prospective Clinical Trial

2020 ◽  
pp. 014556132098019
Author(s):  
Martin Formánek ◽  
Debora Formánková ◽  
Lukáš Školoudík ◽  
Karol Zeleník ◽  
Viktor Chrobok ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Eustachian Tube ◽  
Pure Tone Audiometry ◽  
Adult Patients ◽  
Eustachian Tube Dysfunction ◽  
Prospective Clinical Trial ◽  
Patient Reported ◽  
Tube Dysfunction ◽  
Balloon Eustachian Tuboplasty

Objectives: Balloon eustachian tuboplasty (BET) is a promising therapeutic option for eustachian tube (ET) dysfunction. However, data are lacking on the effect of BET in adults with symptoms of chronic ET dysfunction but without a contributing pathology. This study investigated the effect of BET in adult patients with only symptoms of chronic ET dysfunction. Methods: This prospective clinical trial included adult patients with aerated physiological middle ears and symptoms of ET dysfunction for more than 6 months. Compliance with follow-up was 93.3%. We evaluated the effects of BET with tympanometry, assessment of the Valsalva or Toynbee maneuver with tympanometry verification, a Eustachian Tube Dysfunction Questionnaire (ETDQ-7), and pure-tone audiometry. Data were recorded 1 day before surgery and 2, 6, and 12 months after BET. Therapy was considered successful when the patient exhibited a newly acquired ability to perform the Valsalva or Toynbee maneuver or when the ETDQ-7 score improved by 20% or more. Results: We included 14 ears in the analysis. After 2, 6, and 12 months, therapy was successful, according to the ETDQ-7, in 11/14 (78.6%; 95% CI: 48.8-94.3), 13/14 (92.9%; 95% CI: 64.2-99.6), and 12/14 (85.7%; 95% CI: 56.2-97.5) ears, respectively. These results were statistically significant. The ETDQ-7 scores also significantly decreased at 2, 6, and 12 months after the BET, when any change was observed. All patients experienced improvement. Only 1 patient reported temporary deterioration after 2 months. Treatment was more frequently successful in patients without nasal polyps or pollinosis. Conclusions: Adults with only symptoms of chronic ET dysfunction benefitted more and had longer lasting results from BET, compared to patients with pathologies caused by ET dysfunction. Balloon eustachian tuboplasty could be recommended for these patients.

Telemedicine Video Follow-Up for Bariatric Surgery Patients: What Do Patients Prefer? A Prepandemic Pilot Randomized Clinical Trial

2021 ◽  
pp. 000313482110545
Author(s):  
Alaa Sada ◽  
William S. Harmsen ◽  
Travis J. McKenzie ◽  
Todd A. Kellogg ◽  
Omar Ghanem ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Physical Contact ◽  
Video Group ◽  
To Receive

While the safety of video follow-up in bariatric surgery is established, patients’ perception of telemedicine visits remained unknown. A randomized clinical trial evaluating patients’ perception of video postoperative follow-up (F/U) visits was conducted in the pre COVID-19 era. 24 patients were randomized in the preoperative clinic to receive either in-person or video F/U, and then surveyed about their experience and preference. The majority reported that if they had to do it over, they would prefer a video visit. Among those who received video visits, 11/12 reported that the lack of physical contact was acceptable. 82% of the video group expressed that their visit was better or as good as an in-person visit, while 9% were not sure, and 9% reported that video was worse. This finding suggests that postoperative video follow-up visits are acceptable among bariatric surgery patients and should be offered as an alternative to traditional visits.

scholarly journals Involvement of bone-specific alkaline phosphatase and procollagen I carboxy-terminal propeptide as predictors of early fracture risk in Chinese Children with juvenile osteoporosis: An interventional clinical trial

2018 ◽  
Vol 13 (2) ◽  
pp. 164
Author(s):  
Yu Wang ◽  
Jingxin Zhao ◽  
Lingwei Kong ◽  
Yu Jin
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Alkaline Phosphatase ◽  
Bone Fracture ◽  
Specific Alkaline Phosphatase ◽  
Bone Specific Alkaline Phosphatase ◽  
Low Levels ◽  
Carboxy Terminal ◽  
To Receive

<p class="Abstract">This clinical trial was designed to understand whether the children with juvenile osteoporosis receiving tablet containing vitamin D and calcium had lower incidence of bone fracture compared to the children receiving a diet rich in calcium, vitamin D, and protein. We assessed whether plasma levels of bone-specific alkaline phosphatase (BSAP) and procollagen I carboxy-terminal propeptide levels (PIPC) could be used as predictors of early bone fracture in children. A total of 120 children of either gender with a juvenile osteoporosis were enrolled and randomized (1:1 ratio) to receive tablet containing vitamin D and calcium (n=60) or diet rich in calcium, vitamin D, and protein (n=60), and undergone follow-up for up to 3 years.  Blood sample was collected and BSAP and PIPC levels were measured. The results suggested that therapeutic intervention (vitamin D and calcium) does not predict bone fracture in children. However, correlations analysis revealed that the decreased level of BSAP and PIPC were associated with higher incidence of fracture. The results suggest that the low levels of BSAP and PIPC cause increase susceptibility of fracture among children with juvenile osteoporosis.</p>

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