Prospective study of pathology and radiology data collection in retroperitoneal sarcoma patients

Not Applicable

• Conditions: Health Condition 1: C480- Malignant neoplasm of retroperitoneum

• Registration Number: CTRI/2021/10/037541
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

-primary RPS operated on in the participating center

-primary RPS previously incompletely resected, and operated in the the participating center for completion surgery

-age more than 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 followup

Exclusion Criteria

-Age less than 18 years;

-recurrent tumor

-benign retroperitoneal tumors;

-serious psychiatric disease that precludes informed consent or limits compliance

-impossibility to ensure adequate followup.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study is aimed 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 disease free survival crude cumulative incidence of local recurrence and distant metastasisTimepoint: 3 years

Secondary Outcome Measures

Name	Time	Method
-to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS <br/ ><br>-to prospectively evaluate the impact of multimodality therapy including radiation therapy and chemotherapy <br/ ><br>-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 <br/ ><br>-to utilize collected pathological material for research collaborations. <br/ ><br>Timepoint: 3 years