dtectDx Breast: A serum biomarker test for breast cancer detection used in conjunction with traditional mammography screening.

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 18-18
Author(s):  
Meredith C. Henderson ◽  
Keri Sweeten ◽  
Sherri Borman ◽  
Christa Corn ◽  
Lindsey Gordon ◽  
...  

18 Background: Provista Diagnostics has developed a test that analyzes serum concentrations of 5 protein biomarkers in order to detect breast cancer. The dtectDx Breast test utilizes a proprietary algorithm that has been described previously (Weber et al. 2010). In this study, it was noted that the algorithm performs best in women under age 50. The aim of this study was to evaluate the performance characteristics of dtectDx Breast in women under age 50 in a commercial setting and compare the results with data from the previous clinical study. Methods: The dtectDx Breast test measures the concentrations of IL-8, IL-12, VEGF, CEA, and HGF via ELISA. These data combined with select patient characteristics and Provista’s proprietary algorithm result in a test value that is characterized as normal or elevated. dtectDx Breast test reports issued for women under age 50 were reviewed from a 3-year time period and prescribing physicians were interviewed regarding follow-up care and outcome measures (largely imaging studies, if warranted). Results: Of the 908 patients, 8 samples were rejected based on serum quality. Of the remaining 900 patients, 121 were reported as elevated (12.7%). In 4 cases, these elevated results were confirmed cases of breast cancer. Of these, 2 patients initially showed no screening evidence of cancer, but upon further evaluation (after receipt of dtectDx Breast results) were diagnosed with breast cancer. dtectDx correctly identified DCIS 66% of the time (n=2). Conclusions: These results describe the use of dtectDx Breast in a clinical setting and confirm that the assay behaves similarly to previously published results (Weber et al 2010). While the false-positive rate is higher than predicted (12.7% vs 6.8%), the assay correctly identified 4 of 4 invasive cancers and 2 of 3 DCIS cases. Since two of the invasive cancer cases were originally not detected via standard screening procedures, the assay has demonstrated important clinical utility when used in conjunction with mammography/standard of care. Here we show that, in the commercial patient population, when combined with standard of care, dtectDx Breast improves the detection of breast cancer in women under 50.

2002 ◽  
Vol 41 (01) ◽  
pp. 37-41 ◽  
Author(s):  
S. Shung-Shung ◽  
S. Yu-Chien ◽  
Y. Mei-Due ◽  
W. Hwei-Chung ◽  
A. Kao

Summary Aim: Even with careful observation, the overall false-positive rate of laparotomy remains 10-15% when acute appendicitis was suspected. Therefore, the clinical efficacy of Tc-99m HMPAO labeled leukocyte (TC-WBC) scan for the diagnosis of acute appendicitis in patients presenting with atypical clinical findings is assessed. Patients and Methods: Eighty patients presenting with acute abdominal pain and possible acute appendicitis but atypical findings were included in this study. After intravenous injection of TC-WBC, serial anterior abdominal/pelvic images at 30, 60, 120 and 240 min with 800k counts were obtained with a gamma camera. Any abnormal localization of radioactivity in the right lower quadrant of the abdomen, equal to or greater than bone marrow activity, was considered as a positive scan. Results: 36 out of 49 patients showing positive TC-WBC scans received appendectomy. They all proved to have positive pathological findings. Five positive TC-WBC were not related to acute appendicitis, because of other pathological lesions. Eight patients were not operated and clinical follow-up after one month revealed no acute abdominal condition. Three of 31 patients with negative TC-WBC scans received appendectomy. They also presented positive pathological findings. The remaining 28 patients did not receive operations and revealed no evidence of appendicitis after at least one month of follow-up. The overall sensitivity, specificity, accuracy, positive and negative predictive values for TC-WBC scan to diagnose acute appendicitis were 92, 78, 86, 82, and 90%, respectively. Conclusion: TC-WBC scan provides a rapid and highly accurate method for the diagnosis of acute appendicitis in patients with equivocal clinical examination. It proved useful in reducing the false-positive rate of laparotomy and shortens the time necessary for clinical observation.


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nina Honkanen ◽  
Laura Mustonen ◽  
Eija Kalso ◽  
Tuomo Meretoja ◽  
Hanna Harno

Abstract Objectives To assess the long-term outcome of breast reconstructions with special focus on chronic postsurgical pain (CPSP) in a larger cohort of breast cancer survivors. Methods A cross-sectional study on 121 women with mastectomy and breast reconstruction after mean 2 years 4 months follow up. The mean time from breast reconstruction to the follow-up visit was 4 years 2 months. We studied surveys on pain (Brief Pain Inventory, BPI and Douleur Neuropathique 4, DN4), quality of life (RAND-36 health survey), sleep (insomnia severity questionnaire, ISI), mood (Beck’s Depression Index, BDI; Hospital Anxiety and Depression Scale, HADS), and a detailed clinical sensory status. Patients were divided into three groups: abdominal flap (Deep inferior epigastric perforator flap, DIEP; Free transverse rectus abdominis flap, fTRAM, and Pedicled transverse rectus abdominis flap, pTRAM), dorsal flap (Latissimus dorsi flap, LD and Thoracodorsal artery perforator flap, TDAP), and other (Transverse myocutaneous gracilis flap, TMG; implant). Clinically meaningful pain was defined ≥ 4/10 on a numeric rating scale (NRS). We used patients’ pain drawings to localize the pain. We assessed preoperative pain NRS from previous data. Results 106 (87.6%) of the patients did not have clinically meaningful persistent pain. We found no statistically significant difference between different reconstruction types with regards to persistent pain (p=0.40), mood (BDI-II, p=0.41 and HADS A, p=0.54) or sleep (p=0.14), respectively. Preoperative pain prior to breast reconstruction surgery correlated strongly with moderate or severe CPSP. Conclusions Moderate to severe CPSP intensity was present in 14% of patients. We found no significant difference in the prevalence of pain across different reconstruction types. Preoperative pain associated significantly with postoperative persistent pain.


Author(s):  
Karin Biering ◽  
Morten Frydenberg ◽  
Helle Pappot ◽  
Niels Henrik Hjollund

Abstract Purpose Fatigue following breast cancer is a well-known problem, with both high and persistent prevalence. Previous studies suffer from lack of repeated measurements, late recruitment and short periods of follow-up. The course of fatigue from diagnosis and treatment to the long-time outcome status is unknown as well as differences in the level of fatigue between treatment regimens. The purpose of this study was to describe the long-time course of fatigue from the time of clinical suspicion of breast cancer, its dependence of patient characteristics and treatment regimens and the comparison with the course of fatigue among women with the same suspicion, but not diagnosed with breast cancer. Methods Three hundred thirty-two women referred to acute or subacute mammography was followed with questionnaires from before the mammography and up to 1500 days. Fatigue was measured by the Multidimensional Fatigue Inventory (MFI-20). The women reported their initial level of fatigue before the mammography and thus without knowledge of whether they had cancer or not. Both women with and without cancer were followed. Women with cancer were identified in the clinical database established by Danish Breast Cancer Cooperative Group (DBCG) to collect information on treatment regimen. Results Compared to fatigue scores before diagnosis, women with breast cancer reported a large increase of fatigue, especially in the first 6 months, followed by a slow decrease over time. Despite the long follow-up period, the women with breast cancer did not return to their level of fatigue at time of the mammography. Women without breast cancer, experienced a rapid decrease of fatigue after disproval of diagnosis followed by a steadier period. Conclusions Fatigue is a persistent problem in women diagnosed with breast cancer, even several years following diagnosis and treatment. The women with breast cancer were most affected by fatigue in the first 6 months after diagnosis.


Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.


2020 ◽  
pp. 219256822097964
Author(s):  
Abhinandan Reddy Mallepally ◽  
Bibhudendu Mohapatra ◽  
Kalidutta Das

Study design: Retrospective with prospective follow-up. Objective: Confirming the diagnosis of CES based purely on symptoms and signs is unreliable and usually associated with high false positive rate. A missed diagnosis can permanently disable the patient. Present study aims to determine the relationship between clinical symptoms/ signs (bladder dysfunction) with UDS, subsequently aid in surgical decision making and assessing post-operative recovery. Methods: A prospective follow-up of patients with disc herniation and bladder symptoms from January 2018 to July 2020 was done. All patients underwent UDS and grouped into acontractile, hypocontractile and normal bladder. Data regarding PAS, VAC, GTP, timing to surgery and onset of radiculopathy and recovery with correlation to UDS was done preoperatively and post operatively. Results: 107 patients were studied (M-63/F-44). Patients with PAS present still had acontractile (61%) or hypocontractile (39%) detrusor and with VAC present, 57% had acontractile and 43% hypocontractile detrusors. 10 patients with both PAS and VAC present had acontractile detrusor. 82% patients with acute radiculopathy (<2 days) improved when operated <24 hrs while only 47% showed improvement with chronic radiculopathy. The detrusor function recovered in 66.1% when operated <12 hours, 40% in <12-24 hours of presentation. Conclusion: Adjuvant information from UDS in combination with clinicoradiological findings help in accurate diagnosis even in patients with no objective motor and sensory deficits. Quantitative findings on UDS are consistent with postoperative recovery of patient’s urination power, representing improvement and can be used as a prognostic factor.


2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.


2017 ◽  
Vol 107 (3) ◽  
pp. 180-191 ◽  
Author(s):  
Lourdes Vella ◽  
Cynthia Formosa

Background: We sought to determine patient and ulcer characteristics that predict wound healing in patients living with diabetes. Methods: A prospective observational study was conducted on 99 patients presenting with diabetic foot ulceration. Patient and ulcer characteristics were recorded. Patients were followed up for a maximum of 1 year. Results: After 1 year of follow-up, ulcer characteristics were more predictive of ulcer healing than were patient characteristics. Seventy-seven percent of ulcers had healed and 23% had not healed. Independent predictors of nonhealing were ulcer stage (P = .003), presence of biofilm (P = .020), and ulcer depth (P = .028). Although this study demonstrated that the baseline hemoglobin A1c reading at the start of the study was not a significant predictor of foot ulcer outcome (P = .603, resolved versus amputated), on further statistical analyses, when hemoglobin A1c was compared with the time taken for complete ulcer healing (n = 77), it proved to be significant (P = .009). Conclusions: The factors influencing healing are ulcer stage, presence of biofilm, and ulcer depth. These findings have important implications for clinical practice, especially in an outpatient setting. Prediction of outcome may be helpful for health-care professionals in individualizing and optimizing clinical assessment and management of patients. Identification of determinants of outcome could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.


2021 ◽  
Author(s):  
BERNA KURT ◽  
ZEYNEP SİPAHİ KARSLI ◽  
BERNA ÖMÜR ÇAKMAK ÖKSÜZOĞLU ◽  
EMİNE ÖZTÜRK ◽  
NESLİHAN DEMİRÖRS ◽  
...  

Abstract Background The objective of this study is to evaluate the impact of peripheral neuropathy on the quality of life of breast cancer patients throughout with monthly follow-up during 4 months of paclitaxel treatment.Material and methods The research was conducted with a prospective cross sectional with four follow-ups descriptive design. The study population consisted of female patients with breast cancer at Ankara Oncology Training and Research Hospital between August 2018 and January 2019. Data were collected the ‘’Patient Information Form’’,‘’EORTC C30 Cancer Quality Of Life Questionnaire’’ and ‘’Chemotherapy-Induced Peripheral Neuropathy Assessment Tool’’. The study was undertaken in accordance with the STROBE checklist for cross-sectional studies. Results Of 79 patients included in the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool except for the general activity subdimension were statistically significant in the ratings of 2nd, compared to 1st; 3rd compared to 1st and 2nd; 4th compared to 1st, 2nd, and 3rd follow-up periods. The overall mean of EORTC C30 Cancer Quality of Life Questionnaire, functional subdimension, symptom severity, and general well-being in the evaluations of 2nd, compared with 1st; 3rd compared with 1st and 2nd; 4th compared with 1st, 2nd, and 3rd follow-up periods it was found that the mean values of symptom that decreased gradually were statistically significant.Conclusion The neuropathy scale was found to be higher in 2nd, 3rd, 4th follow-up periods than in 1st follow-up. Also, EORTC C30 Cancer QLQ subdimensions were high initially but gradually decreased after the fourth cycle. Thus, it was found that the increase in neuropathy symptoms negatively affects the quality of life.


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