Improving the inclusion rate in clinical trials of bladder cancer despite COVID-19 pandemic by using ASCO quality training program.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18674-e18674
Author(s):  
Natalia Vidal ◽  
Juan Gomez ◽  
Isabel Galante ◽  
Jose Luis Senovilla ◽  
Jose-Luis Gonzalez-Larriba ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Training Program ◽  
Cancer Patients ◽  
Stage Iv ◽  
Invasive Disease ◽  
Enrollment Rate ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
First Time

e18674 Background: In 2019, we used the American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) as an instrument to improve the inclusion rate in clinical trials (CTs) for bladder cancer patients from 24% in 2018 to 43,75% in 2019. CTs play an important role in developing new treatments, expanding or refining treatments that are already available, and/or identifying behavioral changes that can prolong or improve the lives of subjects. Therefore, we believe it is important for patients and for society to maintain the inclusion rate in clinical trials despite COVID-19 pandemic. Methods: We collected the number of bladder cancer patients evaluated for the first time in the Oncology department, the number of patients who were offered a clinical trial, the screen failures and the number of patients enrolled in CTs. Results: In 2019, we were able to increase the enrollment rate in CTs for bladder cancer patients to from 24% to 43,75% thanks to the ASCO-QTP. With this program we created a list of measures and identified the ones that would have a greater impact. The one that seems to have had the highest impact is the diffusion of CTs in the Investigation Unit and the Genitourinary (GU) board. In 2020, thanks to this measure and despite the COVID-19 pandemic, we were able to maintain a 40,81% enrollment rate. When analyzing the patients evaluated for the first time in the Oncology department, 48 in 2019 and 49 in 2020, there were some interesting differences. In 2020, 42,86% had stage IV disease with respect to 39,6% in 2019, and only 22,44% had non-muscle invasive disease (NMIBC) versus 33,33% in 2019. However, thanks to the diffusion of CTs in the Investigation Unit and in the GU-board, which translates in an early derivation of patients to Medical Oncology and an increase in the number of available CTs, we were able to offer a CT to 73,5% of patients in 2020 against 60,4% in 2019. Although there was an increase of screen failures in 2020 (32,65% vs. 16,66%), 50% of them were due to the absence of a biomarker in a biomarker driven CT, with respect to 25% in 2019. Conclusions: Using ASCO-QTP as an instrument, we identified the importance of the diffusion of CTs and the close collaboration between departments. Maintaining these measures, we were able to uphold the inclusion rate in CTs for bladder cancer patients in 40,81% despite the later diagnosis of patients due to COVID-19 pandemic.

Evaluation of the inclusion rate in clinical trials of bladder cancer patients evaluated for first time in the oncology department.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19219-e19219
Author(s):  
Natalia Vidal ◽  
Javier Puente ◽  
Fernando Moreno ◽  
María del Rosario Alfonso ◽  
Lydia Suárez ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
The Elderly ◽  
Eligibility Criteria ◽  
Enrollment Rate ◽  
Geriatric Evaluation ◽  
Inclusion Rate ◽  
First Time

e19219 Background: In the Genitourinary (GU) Cancer Unit of Clínico San Carlos Hospital the inclusion rate in Clinical-Trials (CTs) from January-October 2018 was 39%. However, in bladder cancer patients it was only 24%. We identified improvement areas in order to increase the inclusion rate of these patients up to 30% from November 2018-March 2019. Methods: We used as an instrument the American Society of Clinical Oncology (ASCO) Quality Training Program (QTP). We collected the number of proposals and available CTs, the number of bladder cancer patients evaluated for the first time and the patients enrolled in CTs. We also identified the causes of non-enrollment and elaborated a list of possible solutions. Results: We developed a cause-effect diagram showing that the most relevant causes of non-enrollment in CTs were the eligibility criteria (60%) and the absence of available CTs (35%). We created a list of measures and identified which would have a higher impact. On November 2018 we started a protocolized Supportive-Care evaluation by our Oncology nurses to increase the number of eligible patients. We also initiated the diffusion of CTs in the Investigation Unit and in the GU-board to increase the number of available CTs and recruitment. In January 2019 we implemented a Geriatric evaluation for the elderly, also to increase the number of eligible patients. With these measures the number of accepted trials increased from 5 in January-October 2018 to 12 in November 2018-March 2019. Also, in January-October 2018, 46% of patients were not-enrolled in a CT due to ineligibility, which decreased to 25% from November 2018-March 2019. As a result, the enrollment rate increased to 43, 75% from November 2018-March 2019. We maintained the measures, and achieved an enrollment rate of 54, 83% from May-December 2019. Conclusions: The implementation of a Supportive-Care and a Geriatric evaluation, and the diffusion of CTs helped increase the percentage of eligible patients and the number of available CTs. With these improvements, we were able to increase the enrollment rate in CTs from 24 to 58, 83%.

Improving the inclusion rate in clinical trials of bladder cancer patients by mapping the quality process of the multidisciplinary team

2021 ◽  
Vol 79 ◽  
pp. S1227
Author(s):  
N. Vidal ◽  
J. Gómez Rivas ◽  
M.I. Galante ◽  
I. De La Parra ◽  
T. Jerez ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Multidisciplinary Team ◽  
Inclusion Rate ◽  
Quality Process

Clinical trials navigator: Patient-centered access to clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14024-e14024
Author(s):  
Caroline M. Hamm ◽  
Krista Naccarato ◽  
Stephen Sundquist ◽  
Suzana Kovacevic ◽  
Youshaa El-Abed ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Trial Design ◽  
Stage Iv ◽  
Trial Participation ◽  
Patient Centered ◽  
Number Of Patients ◽  
Significant Interest ◽  
Status Information ◽  
Turn Around Time

e14024 Background: Despite recommendations from premier institutions such as NCCN that all cancer patients should be entered on clinical trials, only 3 – 5 % of adult cancer patients are enrolled on clinical trials in North America. The reason for this is multi-factorial and includes poor trial design, inappropriate endpoints, inappropriate inclusion/exclusion factors, attitudes about trial participation held by patient and/or treating physician and lack of trial availability. Methods: To address issues of trial availability, in March 2019, we initiated a novel service to help Canadian patients find clinical trial options. The service compares patient demographic and health status information provided against potential opportunities sourced using clinicaltrials.gov and Canadian clinical trials websites. A report presenting outcomes of CTN review is developed for the requesting patient or physician. An interview is provided for the self-referring patient by supporting physicians. Results: To date 96 patients have used this service. Most (94%) were stage IV or refractory/ relapsed. Smaller disease sites represented 23% of our patient population (brain, sarcoma, pancreas). Our turn-around-time from request of services to delivery of report to patient or physician improved over time and is currently 24 hours during the working week. Of those eligible, 25% of patients died before referral, the median time from referral to the CTN to the patient’s death was 109 days (3 – 188 days). Conclusions: Significant interest from both physicians and patients for this service was identified. Strategies are being developed to encourage earlier referrals to clinical trials would improve number of patients entering clinical trials as 25% of our patients. [Table: see text]

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

INDUSTRIAL ACTIVITY REVIEW OF THE FRENCH NETWORK OF PEDIATRIC CLINICAL INVESTIGATION CENTERS (FN-PCIC) 2008–2013

2015 ◽  
Vol 101 (1) ◽  
pp. e1.27-e1
Author(s):  
Elsa Maksooud ◽  
Evelyne Jacqz-Aigrain
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
European Medicines Agency ◽  
University Hospitals ◽  
European Regulation ◽  
Clinical Investigations ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
The Impact ◽  
Drug Studies

IntroductionThe French Network of Pediatric Clinical Investigations Centers (FN-PCIC) created in 2000 includes today 16 CIC grouped under the auspices of the INSERM and the corresponding public university hospitals. In response to the European pediatric regulation published in 2007, all pharmaceuticals laboratories, in order to complete their drug profile, must conduct pediatric clinical trials according to the Pediatric Clinical Investigation Plan and validated by the European Medicines Agency (EMA). This network plays a major role in facilitating and optimizing the conduction of nation-wide pediatric clinical trials. Therefore, the PN-CIC plays a major role to response to this acute demand in the pediatric field. The purpose of this review is to sum up the activity of the FN-PCIC between 2008 and 2013 and to analyze the impact of the European regulation.MethodsOnly the industrial protocols will be analyzed, for every protocol a certain number of information was collected such as the pharmaceutical industry, the therapeutic fields, the phase of the study, the duration of the study, the methodology, and the number of patients needed.Results261 protocols were active during this period by 90 different sponsors. 218 were interventional studies and 43 were observational or non-drug studies (registers, post-AMM). The number of active studies was at 127 in 2013 compared to 76 in 2008. Furthermore, the total number of participations were 242 for 16 CIC in 2013 compared to 110 in 2008. The mean inclusion rate was 87%. The percentage of the common studies rises from 36% in 2008 to 50% in 2013. In addition, the feasibility study demands increased and were as high as 57, an average of one demand per week The inclusion percentage calculated using the data of the closed studies is at 87%. The therapeutic fields concerned were nephrology and oncology (15%), then neurology and pneumology (13%).ConclusionActivity increased, linked to the national coverage now including 16 centers and high quality procedures to perform pediatric research trials under high ethical and quality standards.

scholarly journals Survival Outcomes in Stage IV Bladder Cancer Patients Treated with Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine: A Retrospective Analysis in Veteran Patients

2020 ◽  
pp. 1-4
Author(s):  
Anuradha Kunthur ◽  
Anuradha Kunthur ◽  
Eric Siegel ◽  
Rangaswamy Govindarajan
Keyword(s):  
Bladder Cancer ◽  
Cancer Patients ◽  
Cox Regression ◽  
Performance Status ◽  
Stage Iv ◽  
Rank Test ◽  
Poor Performance Status ◽  
Health Administration ◽  
Standard Regimen ◽  
Urothelial Bladder

Purpose: Gemcitabine/cisplatin (GCi) is the standard regimen used to treat stage IV urothelial bladder cancers. However, most of the bladder cancer patients are older, with poor performance status and renal dysfunction, and are not eligible for cisplatin-containing regimens. There are no randomized studies comparing gemcitabine/carboplatin (GC) and gemcitabine/cisplatin (GCi). Methods: We identified stage IV bladder cancer patients treated within the Veterans Health Administration (VHA), healthcare system between January 2000 and December 2010 from Veterans Affairs Central Cancer Registry (VACCR). Overall survival (OS) was visualized using Kaplan-Meier curves and tested for the significance of the treatment-arm difference using the log-rank test. Results: There were 196 patients with stage IV bladder cancer, out of which 78 patients were treated with GC and 118 patients treated with GCi. The median OS for all patients was 12.5 months a 95% confidence interval (CI) of 10.0-14.6 months. The median OS for patients treated with GC was 13.4 months (95% CI 9.8-17.5 months), and that of the patients treated with GCi was 11.7 months (95% CI 9.3-14.9 months). Cox regression revealed equal group mortality rates, with GC having a (hazard ratio (HR) of 0.96 (CI 0.72-1.27; P= 0.81)) compared to GCi. Conclusion: Our study is the largest comparing GC and GCi in stage IV urothelial bladder cancer patients. It showed that there is no difference in OS in patients treated with GC and GCi.

The predictive value of hENT 1 molecule for gemcitabine treatment in bladder cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15540-e15540
Author(s):  
Didem Sener Dede ◽  
Aydan Kilicaslan ◽  
Muhammed Bulent Akinci ◽  
Umut Demirci ◽  
Gozde Tahtaci ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Cancer Patients ◽  
Predictive Value ◽  
Stage Iv ◽  
Response To Therapy ◽  
Stage Iii ◽  
Low Grade ◽  
Nucleoside Transporter ◽  
Control Tissue ◽  
Significant Difference

e15540 Background: Human equilibrative nucleoside transporter 1 (hENT1) is the nucleoside transporter protein which plays the main role for transportation of gemcitabine into the cells. We aim to assess the predictive value of the hENT 1 molecule in bladder cancer patients treated with gemcitabine based chemoterapy. Methods: Clinically and histologically documented stage III and stage IV invazive bladder cancer patients were included in the study. The patients were assessed retrospectively. All patients were received gemsitabine-platine based chemotherapy as the first line treatment. Spesific hENT1 antibody staining was performed on the chemo-naive bladder tumor specimens immunuhistochemically. Vascular endotel and lymphocytes served as an external positive control for hENT 1 immunuhistochemistry. Staining intensity was graded as 0,absent; 1+, less intens than control tissue, 2, equally positive as control tissue; 3, more intense than control tissue. Tumor spesimens with having 3+ intensity staining in >50% of the tumor cells were accepted as showing high expression of hENT 1. Results: Fifty one patients were included in the study. The median age was 67 (range 41-85). Ninety two percent(n=52) of patients were male. Twenty six (46.4%) and 25 (44.6%) patients were stage III and stage IV disease at the beginning of the therapy, respectively. Thirty four (60.7%) patients were in neoadjuvant treatment group and 17 (30.4%) patients were in metastatic group. Tumor grades could be assessed in 33 patients; 2 (11.4%) were low grade and 31 (88%) were high grade. The median folllow up period was 13 (range 1-58) months. In neoadjuvant group 5 (14%) patients have low hENT 1 level and 21 (60%) patients have high hENT 1 level. In metastatic group 1 (5%) patients have low hENT1 level and 13 (95%) patients have high hENT 1 level. We found no statistically significant difference between hENT 1 low and hENT 1 high groups in terms of response to therapy in metastatic and neoadjuvant groups (p=0.426 and p=0.684 respectively). Conclusions: More stuides are needed to demonstrate the real role of hENT 1 molecule in terms of response to gemsitabine treatment.

Appropriate endpoints for superficial bladder cancer clinical trials.

1987 ◽  
Vol 5 (12) ◽  
pp. 2004-2008 ◽  
Author(s):  
L A Kalish ◽  
M B Garnick ◽  
J P Richie
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Clinical Outcome ◽  
Superficial Bladder Cancer ◽  
Invasive Disease ◽  
Actual Data ◽  
Cancer Clinical Trials ◽  
Data Sets ◽  
End Points

Many protocols for treatment of superficial bladder cancer include periodic cystoscopic examinations with resection of visible lesions. This allows pathological restaging of the disease at each examination. For example, this type of follow-up is common in clinical trials evaluating intravesical therapies. In such trials, clinical outcome is typically summarized using end-points that measure failure to control superficial disease. Alternative endpoints measuring failure to prevent progression to invasive disease are often ignored. In this report, the rationale for ignoring the invasive disease endpoints is given and flaws in the rationale are described. Evidence from actual data sets support the view that superficial disease endpoints may not be appropriate surrogates for invasive disease endpoints. It is recommended that time to invasive disease should be considered a major endpoint when designing and analyzing trials in superficial bladder cancer.

scholarly journals Psychosocial and Functional Distress of Cancer Patients in A Tertiary Care Hospital: A Descriptive Cross-sectional Study

2019 ◽  
Vol 57 (218) ◽  
Author(s):  
Guru Sharan Sah
Keyword(s):  
Cancer Patients ◽  
Stage Iv ◽  
Cross Sectional Study ◽  
Distress Thermometer ◽  
Care Hospital ◽  
Care Providers ◽  
Sectional Study ◽  
Cross Sectional ◽  
Number Of Patients ◽  
Patient Department

Introduction: Global burden of cancer is witnessing an exponential increase. Nepal is no exception. In the recent years, cancer care has seen a focus shift towards holistic healing. This includes screening and assessing for psychosocial distress, allowing health care providers to deliver timely psychological interventions. The goal of this study was to find the prevalence of psychosocial and functional impact of cancer diagnoses in Nepal. Methods: A descriptive cross-sectional study was carried out on 169 cancer patients attending out-patient department, day-care and in-patient department at B.P. Koirala Memorial Cancer Hospital, Nepal. National Comprehensive Cancer Network Distress Thermometer was used to evaluate spiritual/religious concerns, practical, family, emotional and physical issues and the distress score of these patients. Results: One-hundred and thirty eight (81.7%) of respondents had a Distress Thermometer score of ≥4. Distress Thermometer score of 7 was reported by the largest number of patients. Highest average Distress Thermometer scores were found in patients with hepatobiliary, head & neck and lung cancers. More than 50% of the patients reported to experience spiritual or religious concerns, fatigue, pain, worry and insurance or financial related concerns. Pain, sadness, worry and spiritual/religious concerns were significantly associated with distress levels. Sixty-two (36.7%) of respondents were in stage IV of cancer. Average Distress Thermometer score for patients in stage IV cancer was 5.69, the highest among all cancer stages. Ninety-six (56.8%) of the respondents were females, 73 (43.2%) were males. Gynaecological, haematological, gastrointestinal, head & neck and breast cancers were the top 5 cancer types. Conclusions: Cancer patients in Nepal have clinically significant psychosocial issues that directly impact on their distress.

scholarly journals Smoking’s Negative Effect on Pathological Grade and Stage in Patients with Primary, Single, < 3cm Bladder Cancer

2018 ◽  
Author(s):  
Ercan Öğreden ◽  
Ural Oğuz ◽  
Erhan Demirelli ◽  
Orhan Yalçın
Keyword(s):  
Bladder Cancer ◽  
Potential Effect ◽  
Low Grade ◽  
Number Of Patients ◽  
Negative Effect ◽  
Risk Patients ◽  
Smoking Group ◽  
Never Smokers ◽  
First Time ◽  
Single Lesion

Introduction: We investigated the potential effect of smoking on pathological staging in clinically low-risk patients. Material-Methods: Data of 59 patients who were diagnosed with a bladder tumor for the first time and had a single lesion radiologically and endoscopically smaller than 3 cm were investigated, retrospectively. A total of 33 patients who currently smoke or smoked were classified as ever smokers group and 26 patients who did not ever smoke were classified as never smokers group. Pathological diagnoses of the patients in both groups were compared. Results: A total of 9 patients (27.3%) in ever smokers group and 18 patients (69.2%) in never smokers group had Ta disease (p&lt;0.05). Morover, 19 patients (57.6%) in ever smokers group and 5 patients (19.2%) in never smokers group had T1 disease (p&lt;0.05). The number of patients with low grade (LG) tumor were 8 (24.2%) and 19 (73.1%) in ever smoking and never smoking groups, respectively (p&lt;0.05). The number of patients with high grade (HG) tumor were 25 (75.8%) and 7 (26.9%) in ever smoking and never smoking groups, respectively (p&lt;0.05). Ta HG was detected in 9 (27.3%) patients in ever smoking group. In contrast, no patients in never smoking group had Ta HG disease (p&lt;0.05). The number of patients with T1 HG was 17 (51.5%) in ever smoking group and 2 (7.69%) in never smoking group (p&lt;0.05). Conclusion:Smoking seems to associate with pathologically worse stage and grade in patients with primary, single, &lt; 3cm bladder cancer.

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