NCT05739084

Brief Summary

To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2025

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

January 26, 2023

Last Update Submit

February 20, 2023

Conditions

Soft Tissue Sarcomas

Outcome Measures

Primary Outcomes (1)

  • To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint

    Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.

    36 months

Secondary Outcomes (1)

  • To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints

    36 months

Study Arms (2)

Retrospective cohort

A total sample size of 200 patients is expected in the retrospective thanks to the NETSARC/ CONTICABASE databases (French sarcoma reference network)

Radiation: pre-operative radiationProcedure: Standard surgery after rpreoprative radiation

Prospective cohort

To ensure an external validation, patients from NETsarc centers experiencing preoperative RT will be prospectively accrued and transcriptomic signature will be tested. Up to 100 patients will be enrolled in this prospective cohort.

Radiation: pre-operative radiationProcedure: Standard surgery after rpreoprative radiation

Interventions

pre-operative radiationRADIATION

As per standard of care and institutional guidelines

Prospective cohortRetrospective cohort
Standard surgery after rpreoprative radiationPROCEDURE

As per standard of care and institutional guidelines

Prospective cohortRetrospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Soft tissus sarcoma who underwent/undergo to preoperative Radiation and for whom resected tumour specimen is available.

You may qualify if:

  • Male and female ≥ 18 years at time of non-opposition to participate to the study
  • Patient with documented non-opposition to participate to the study.
  • Patient with histologically and cytologically confirmed diagnosis with STS (..)
  • Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
  • Patients with tumor FFPE samples prepared with the last 4 years
  • Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..)

You may not qualify if:

  • Patients with metastatic soft tissue sarcoma at diagnosis
  • Patients with exclusive radiotherapy without surgical resection
  • Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Available FFPE Tumour samples at diagnosis and surgery from respectively Retrospective cohort \[200 patients\] and Propective Cohort \[100 patients\]

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Marie -Pierre SUNYACH, MD

CONTACT

+33(0)4 78 78 28 28MariePierre.SUNYACH@lyon.unicancer.fr

Waisse Waissi, MD

CONTACT

+33(0)4 78 78 28 28Waisse.WAISSI@lyon.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 22, 2023

Study Start

November 23, 2022

Primary Completion

June 23, 2025

Study Completion

November 23, 2025

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)