Collection of Primary Retroperitoneal Sarcoma Data, Radiological, and Pathological Material for the Transatlantic Australasian Retroperitoneal Sarcoma Working Group
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-008260
Sponsor Protocol Number: RESAR
About this study
The purpose of this study is to prospectively collect standardized clinical data and radiological and pathological material from primary retroperitoneal sarcomas 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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Primary RPS operated on in the participating center.
- Primary RPS who undergo incomplete resection at another hospital and therefore candidate to completion surgery of persistent primary disease in the participating center.
- Primary RPS candidate to neoadjuvant treatment in the participating center and not receiving surgery for whichever reason.
- Age>18 years at the time of the first treatment (pediatric patients can not be included).
- Histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist.
- Radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection.
- Signed informed consent form.
- Adequate compliance of the patients to the plan of follow-up.
Exclusion Criteria:
- Age < 18 years.
- Recurrent tumor.
- Benign retroperitoneal tumors.
- Serious psychiatric disease that precludes informed consent or limits compliance.
- Impossibility to ensure adequate follow-up.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/16/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Sanjay Bagaria, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available