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NCT03838718 · ClinicalTrials.gov registry record
REtroperitoneal SArcoma Registry: an International Prospective Initiative
A clinical trial of Retroperitoneal Sarcoma, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 20
- Study locations
NCT03838718: Recruiting study of Retroperitoneal Sarcoma, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
NCT03838718 is a study of Retroperitoneal Sarcoma that is actively recruiting participants, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The registered enrollment target is 2,000 participants, above the 83-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (2310% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03838718, a study of Retroperitoneal Sarcoma, is actively recruiting participants, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: * to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. * patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: * to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; * to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; * to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; * to utilize collected pathological material for research collaborations.
Primary Outcome
Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.
Conditions Studied
Study Locations (20)
Other
- Peter MacCallum Cancer Center - Melbourne
- Maisonneuve-Rosemont Hospital / University of Montreal - Montreal
- The Ottawa Hospital - Ottawa
- Mount Sinai / Princess Margaret - Toronto
- Institut Curie - Paris
- University Medical Center and Medical Faculty Mannheim, University of Heidelberg - Mannheim
- Ludwig Maximilian University - Munich
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- Veneto Institute of Oncology - Padua
- Ospedale Borgo Roma - Verona
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
- Institute of Oncology Ljubljana - Ljubljana
- Samsung Medical Center - Seoul
- Hospital Clinico Universitario "Virgen de la Arrixaca" - Murcia
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
California
- University of Southern California (USC) - Los Angeles
Georgia
- Winship Cancer Institute - Emory
Massachusetts
- Brigham and Women's Hospital/Dana-Farber Cancer Institute - Boston
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2030-12-31 |
What NCT03838718 shows while recruiting
NCT03838718 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 83-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (2310% higher).
The record links to 1 condition, with Retroperitoneal Sarcoma appearing as the primary indexed condition, and to 0 interventions.
NCT03838718 names 20 study sites across 6 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT03838718 about?
NCT03838718 is a clinical study titled "REtroperitoneal SArcoma Registry: an International Prospective Initiative". Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a to...
What is the current status of trial NCT03838718?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2016-09-01. Estimated completion is 2030-12-31.
What conditions does trial NCT03838718 study?
This clinical trial studies the following conditions: Retroperitoneal Sarcoma.
Who is sponsoring clinical trial NCT03838718?
This trial is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03838718 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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