scholarly journals Challenges on participation in a cooperative group of childhood renal tumors in Brasil

2020 ◽  
Vol 66 (3) ◽  
pp. 284-289
Author(s):  
Lucian S. Viana ◽  
Neimar de Paula Silva ◽  
Nathalie V. Balmant ◽  
Paulo A. Faria ◽  
Marceli O. Santos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Renal Tumor ◽  
Wilms Tumor ◽  
Cancer Registries ◽  
Geographic Region ◽  
Renal Tumors ◽  
Trial Participation ◽  
Cooperative Group ◽  
Cooperative Groups ◽  
Accrual Rate

SUMMARY OBJECTIVE Children with renal tumors included in clinical trials have significantly better outcomes. In Brasil, the enrollment of patients in clinical trials remains challenging. Here we aimed to describe participation accrual in the Brazilian Wilms Tumor Study Group (BWTSG) and to identify barriers to trial registration of children with renal tumors. METHODS We determined the numbers of renal tumor diagnoses in 105 hospital-based cancer registries from 2001-2009. We then compared these totals with the numbers of renal tumor cases registered in the BWTSG from the same hospitals during the same time period. We also invited members of the Brazilian Pediatric Oncology Society to complete a 5-point Likert-type scale questionnaire regarding their opinions of the importance of participation in cooperative group trials. RESULTS The accrual rate of patient participation per hospital varied from 25% to 76%, and was highest in the South region. The accrual rate of hospital participation also varied according to the region (20-31%) and was highest in the Southeast region. For the questionnaire regarding the importance of participation in cooperative groups, the responses showed an agreement of >75% on 10 of the 13 statements. CONCLUSION Our results demonstrated low accrual of participation in a cooperative group trial in Brasil. We identified variations in registration rates according to geographic region and hospital, which may help targeted efforts to increase registration rates. The survey responses demonstrated that colleagues understand the importance of trial participation.

scholarly journals Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5051-5057 ◽  
Author(s):  
Deborah Watkins Bruner ◽  
Charlene J. Bryan ◽  
Neil Aaronson ◽  
C. Craig Blackmore ◽  
Michael Brundage ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Cancer Control ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Cooperative Groups ◽  
End Points ◽  
Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

Poor access to clinical trials among community cancer patients requiring chemotherapy for recurrent or progressive disease: Limitations of current cancer cooperative groups

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6076-6076 ◽  
Author(s):  
L. A. Meyer ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
K. A. Frisby ◽  
K. C. Bruden ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Progressive Disease ◽  
Cancer Center ◽  
Cooperative Groups ◽  
Newly Diagnosed ◽  
Poor Access ◽  
Accrual Rate ◽  
Clinical Trial Accrual ◽  
A Prospective Study

6076 Background: Data on clinical trial accrual among cancer patients treated in the community are limited. In a prospective study at our community-based cancer center, we found that the accrual rate was only 4% for newly diagnosed patients and protocol limitations accounted for 68% of non-accrual (Go RS, et al. Cancer 2006). We would like to determine the availability of trials for adult cancer patients with recurrent or progressive disease treated in the community and the accrual rate. Methods: We retrospectively identified this specific group of patients who received chemotherapy at our institution between November 2004 and October 2005 and collected data on the number, types, and sources of trials that were available. Results: We identified a total of 140 patients. There was an equal number of females (52.9%) and males, with a median age of 66 years (range, 38–89) at the time of chemotherapy. Fifty trials were available, with about half for the following cancers: lung (14%), pancreatic (12%), renal (10%), head and neck (8%), prostate (6%), and breast (6%). No trials were available for bladder, colorectal, and gastroesophageal cancers. The proportions of phase I, II, and III trials were 4%, 62%, and 34%, respectively. The sources of trials were: ECOG (56%), Wisconsin Oncology Network (14%), Intergroup (12%), GOG (10%), RTOG (2%), CTSU (2%), our institution (2%), and pharmaceutical companies (2%). Only 69 (49.3%) patients had trials appropriate for their type and stage of cancers. Among those patients with available trials, 24 (34.8%) were eligible to participate and 6 were enrolled, for an overall accrual rate of 4.3%. There were no differences in age and sex among subgroups in terms of trial availability, eligibility, and accrual. Conclusions: At our institution, enrollment of cancer patients with recurrent or progressive disease in clinical trials is as low as for newly diagnosed patients. Over 80% of the patients were denied access to a trial because of protocol unavailability and ineligibility. Current cancer cooperative groups do not provide adequate trials for patients in the community. No significant financial relationships to disclose.

scholarly journals Childhood Renal Tumor: A Report from a Chinese Children’s Cancer Group

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Jiaoyang Cai ◽  
Ci Pan ◽  
Qin Lu ◽  
Jie Yan ◽  
Xiuli Ju ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Renal Tumor ◽  
Survival Rates ◽  
Renal Tumors ◽  
Group Model ◽  
Cooperative Group ◽  
Event Free Survival ◽  
Female Ratio ◽  
Free Survival ◽  
Favorable Histology

Here we investigated the establishment of multicenter cooperative treatment groups in China, as well as radiotherapy compliance and effectiveness among children with renal tumors. Medical records were reviewed for 316 children with renal tumors diagnosed by a multicenter cooperative group from 14 hospitals in China from 1998 to 2012. Median patient age was 29.5 months (range, 2–173 months old), and male-to-female ratio was 1.4 : 1. After a median follow-up of 22 months (range, 1–177 months), five-year event-free survival rates were 72% overall; 76.1% for favorable histology (251 cases); 59% for unfavorable histology (27 cases); and 91%, 75%, 71%, 53%, and 48.5%, respectively for Stages I, II, III, IV, and V. Following standardized criteria, radiation therapy was indicated for 153 patients, among whom five-year event-free survival was 72.8% for the 95 who received radiation and 24% for the 58 patients who did not. Our results are reasonable but can be further improved and show the feasibility of a multicenter cooperative group model for childhood renal tumor treatment in China. Radiation therapy is important for stage III and IV patients but remains difficult to implement in some parts of China. Government management departments and medical professionals must pay attention to this situation. This clinical trial is registered with ChiCTR-PRCH-14004372.

scholarly journals A case of Wilms tumor with right ventricular extension of tumor thrombus

2017 ◽  
Vol 4 (1) ◽  
pp. 60
Author(s):  
Mustafa Çakan ◽  
Ayşe Gülnur Tokuç ◽  
Kıvılcım Karadeniz Cerit ◽  
Koray Ak ◽  
Rabia Ergelen
Keyword(s):  
Inferior Vena Cava ◽  
Right Ventricle ◽  
Right Atrium ◽  
Tumor Thrombus ◽  
Inferior Vena ◽  
Renal Tumor ◽  
Wilms Tumor ◽  
Vena Cava ◽  
Renal Tumors ◽  
Tumor Extension

Primary renal tumors comprise 6% of all childhood cancers. Wilms tumor is the most common primary renal tumor in pediatric age group and the peak age of diagnosis is 3-4 years. In 10% of cases tumor extension into hepatic vein and inferior vena cava can be seen. But tumor extension into whole inferior vena cava, right atrium and right ventricle is only seen in less than 1% of patients. A 2-year-old girl was admitted to the hospital because of abdominal distension that was noticed by the parents two weeks ago. Imaging studies revealed that she had a mass at the right renal lodge which was favoring to Wilms tumor and on thorax tomography tumor thrombus was seen in the whole inferior vena cava, right atrium and right ventricle. Neoadjuvant chemotherapy was given for 7 weeks. On the 8th week of diagnosis, under cardiopulmonary bypass, surgical operation by pediatric and cardiovascular surgery teams for primary renal tumor and for cavo-atrial tumor thrombus was performed. Pathological examination of the mass was reported as stage 3 diffuse anaplastic Wilms tumor. The patient completed 24 weeks of chemotherapy protocol and she is being followed for 15 months without any morbidity. We present our case to emphasize the importance of multidisciplinary approach in Wilms tumor with cardiac extension.

A Composite Renal Tumor: Metanephric Adenofibroma, Wilms Tumor, and Renal Cell Carcinoma: A Missing Link?

2012 ◽  
Vol 15 (1) ◽  
pp. 65-70 ◽  
Author(s):  
Maria Laura Galluzzo ◽  
Maria T. Garcia de Davila ◽  
Gordan M. Vujanić
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Renal Tumor ◽  
Wilms Tumor ◽  
Papillary Renal Cell Carcinoma ◽  
Renal Tumors ◽  
Metanephric Adenoma ◽  
Missing Link ◽  
Additional Support

A coexistence of different renal tumors has rarely been reported. The most commonly described association is of Wilms tumor and renal cell carcinoma. Metanephric adenofibroma has also been associated with Wilms tumor or papillary renal cell carcinoma. Another reported association is metanephric adenoma and papillary renal cell carcinoma with sarcomatoid dedifferentiation. Herein we describe a complex renal tumor containing areas of metanephric adenofibroma, Wilms tumor, and undifferentiated renal cell carcinoma in a previously healthy 18-year-old boy. The tumor showed histologic and immunohistochemical features of these 3 different tumors, offering additional support to the view that these 3 tumors are related.

scholarly journals Intra-tumor genetic heterogeneity in Wilms tumor samples

2019 ◽  
Vol 65 (12) ◽  
pp. 1496-1501 ◽  
Author(s):  
Bruna M de Sá Pereira ◽  
Rafaela Montalvão de Azevedo ◽  
Joaquim Caetano de Aguirre Neto ◽  
Clarice Franco Menezes ◽  
Karla Emília Rodrigues ◽  
...  
Keyword(s):  
Molecular Markers ◽  
Genetic Heterogeneity ◽  
Renal Tumor ◽  
Wilms Tumor ◽  
Renal Tumors ◽  
Childhood Cancers ◽  
Tumor Group ◽  
Somatic Alterations ◽  
Low Prevalence ◽  
High Degree

SUMMARY Childhood renal tumors account for ~7% of all childhood cancers, and most cases are embryonic Wilms’ tumors (WT). Children with WT are usually treated by either COG or SIOP. The later treats the children using preoperative chemotherapy, but both have around 90% of overall survival in five years. WT is a genetically heterogeneous group with a low prevalence of known somatic alterations. Only around 30% of the cases present mutation in known genes, and there is a relatively high degree of intra-tumor genetic heterogeneity (ITGH). Besides potentially having an impact on the clinical outcome of patients, ITGH may interfere with the search for molecular markers that are prospectively being tested by COG and SIOP. In this review, we present the proposal of the current UMBRELLA SIOP Study 2017/Brazilian Renal Tumor Group that requires the multi-sampling collection of each tumor to better evaluate possible molecular markers, as well as to understand WT biology

scholarly journals Advances in Wilms Tumor Treatment and Biology: Progress Through International Collaboration

2015 ◽  
Vol 33 (27) ◽  
pp. 2999-3007 ◽  
Author(s):  
Jeffrey S. Dome ◽  
Norbert Graf ◽  
James I. Geller ◽  
Conrad V. Fernandez ◽  
Elizabeth A. Mullen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
International Collaboration ◽  
Wilms Tumor ◽  
Study Groups ◽  
Renal Tumors ◽  
Laboratory Research ◽  
Molecular Features ◽  
Large Patient ◽  
Response To Chemotherapy ◽  
Patient Subgroups

Clinical trials in Wilms tumor (WT) have resulted in overall survival rates of greater than 90%. This achievement is especially remarkable because improvements in disease-specific survival have occurred concurrently with a reduction of therapy for large patient subgroups. However, the outcomes for certain patient subgroups, including those with unfavorable histologic and molecular features, bilateral disease, and recurrent disease, remain well below the benchmark survival rate of 90%. Therapy for WT has been advanced in part by an increasingly complex risk-stratification system based on patient age; tumor stage, histology, and volume; response to chemotherapy; and loss of heterozygosity at chromosomes 1p and 16q. A consequence of this system has been the apportionment of patients into such small subgroups that only collaboration between large international WT study groups will support clinical trials that are sufficiently powered to answer challenging questions that move the field forward. This article gives an overview of the Children's Oncology Group and International Society of Pediatric Oncology approaches to WT and focuses on four subgroups (stage IV, initially inoperable, bilateral, and relapsed WT) for which international collaboration is pressing. In addition, biologic insights resulting from collaborative laboratory research are discussed. A coordinated expansion of international collaboration in both clinical trials and laboratory science will provide real opportunity to improve the treatment and outcomes for children with renal tumors on a global level.

scholarly journals Characteristics and outcome of children with renal tumors in the Netherlands: The first five-year’s experience of national centralization

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0261729
Author(s):  
Prakriti Roy ◽  
Sophie E. van Peer ◽  
Martin M. de Witte ◽  
Godelieve A. M. Tytgat ◽  
Henrike E. Karim-Kos ◽  
...  
Keyword(s):  
The Netherlands ◽  
Pediatric Oncology ◽  
Renal Tumor ◽  
Wilms Tumor ◽  
Survival Rates ◽  
Renal Tumors ◽  
Childhood Malignancies ◽  
Netherlands Cancer Registry ◽  
Central Pathology ◽  
Centralized Care

Around 6% of all childhood malignancies represent renal tumors, of which a majority includes Wilms tumor (WT). Although survival rates have improved over the last decades, specific patients are still at risk for adverse outcome. In the Netherlands, since 2015, pediatric oncology care for renal tumors has been centralized in the Princess Máxima Center for Pediatric Oncology. Here, we describe experiences of the first 5 years of centralized care and explore whether this influences the epidemiological landscape by comparing data with the Netherlands Cancer Registry (NCR). We identified all patients <19 years with a renal mass diagnosed between 01-01-2015 and 31-12-2019 in the Princess Máxima Center. Epidemiology, characteristics and management were analyzed. We identified 164 patients (including 1 patient who refused consent for registration), in our center with a suspicion of a renal tumor. The remaining 163 cases included WT (n = 118)/cystic partially differentiated nephroblastoma (n = 2)/nephrogenic rests only (n = 6) and non-WT (n = 37). In this period, the NCR included 138 children, 1 17-year-old patient was not referred to the Princess Máxima Center. Central radiology review (before starting treatment) was performed in 121/163 patients, and central pathology review in 148/152 patients that underwent surgery. Treatment stratification, according to SIOP/EpSSG protocols was pursued based on multidisciplinary consensus. Preoperative chemotherapy was administered in 133 patients, whereas 19 patients underwent upfront surgery. Surgery was performed in 152 patients, and from 133 biomaterial was stored. Centralization of care for children with renal tumors led to referral of all but 1 new renal tumor cases in the Netherlands, and leads to referral of very rare subtypes not registered in the NCR, that benefit from high quality diagnostics and multidisciplinary decision making. National centralization of care led to enhanced development of molecular diagnostics and other innovation-based treatments for the future.

Multiple uses for a clinical research database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17037-17037
Author(s):  
A. O. Greco ◽  
C. M. Licavoli ◽  
L. A. White ◽  
J. R. Eckardt ◽  
K. O. Easley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Base ◽  
Metastatic Breast ◽  
Trial Participation ◽  
Research Database ◽  
Cooperative Group ◽  
Oncology Clinical Trials ◽  
Referring Physicians

17037 Background: In Sept 2000, the research staff at The Center for Cancer Care and Research (TCCCR) developed an excel data base to track new consults referred to the practice. It is used to identify pts for participation in Cooperative Group Clinical Trials and to identify gaps in the active protocol list. Several additional uses for the data base have evolved. Methods: Medical records provided by referring physicians for each new consult are evaluated by a Research Coordinator. Information including the pt's name, date of visit, physician, referring physician, diagnosis, protocol for which the pt is evaluated, and eligibility information is entered in the data base. Results: The data base provides a method by which we can follow pts through the protocol selection and informed consent process. Early on, the data base identified a site need for trials in metastatic breast cancer prompting us to search other sources such as the CTSU and industry. Additionally, the percentage of new consults actually enrolled on a clinical trial can be determined as well as tracking eligibility/ineligibility trends. The Pharmaceutical Research Dept can use the information to complete feasibility studies prior to participating in industry trials. The data base can be used to evaluate trends in referral patterns and has helped identify referring physicians who support our research efforts. In 2006, TCCCR had a protocol available for 45% of new consults with a cancer dx. Of those pts, 16% enrolled on a Cooperative Group Clinical Trial. According to published evaluations, 16% is well above the national average of pts who participate in oncology clinical trials. It is our assessment that TCCCR's success is due in part to the data base. Conclusions: It is well known that in order to improve treatment outcomes and diminish treatment toxicity, oncology practices and pts must participate in clinical research. It is also well known that the numbers of pts who participate in oncology clinical trials is dismal. This data base has become a valuable tool providing a method to identify and evaluate some of the reasons why pts do not enroll in clinical trials and given our practice guidance to increase pt participation. Our next goal is to evaluate the differences between the rural and urban population at TCCCR's two sites to identify additional trends in clinical trial participation. No significant financial relationships to disclose.

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