NCT02849158

Brief Summary

Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

6.1 years

First QC Date

July 13, 2016

Last Update Submit

November 28, 2023

Conditions

Rectum Adenocarcinoma

Keywords

RectoscopyProctectomyFibroblasts

Outcome Measures

Primary Outcomes (1)

  • Proteomic level evaluation in intra-tumor fibroblast

    Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)

    3 years

Secondary Outcomes (1)

  • Study of fibroblast impact on colorectal tumor cells (in vitro)

    3 years

Other Outcomes (3)

  • Metastatic spread evaluation

    3 years

  • Outcomes 1 to 3 correlation with histological response after RT-CT

    3 years

  • Disease-free survival

    5 years

Study Arms (1)

Biopsy

EXPERIMENTAL

Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum.

Other: Biopsy

Interventions

BiopsyOTHER

Rectoscopy with biopsy

Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+
  • Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography
  • Age ≥ 18
  • No contraindication to treatment with capecitabine
  • Able to receive radiotherapy 50 Grays in 5 weeks
  • No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy
  • Patient or legal representative provided with information and signature of informed consent

You may not qualify if:

  • High rectum adenocarcinoma
  • Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin \> 160 grams) that cannot be interrupted
  • Pregnant woman or breastfeeding
  • Persons deprived of their liberty, or under guardianship
  • Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
  • Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery
  • Patient not covered by health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

INSTITUT CURIE - Site Paris

Paris, 75005, France

Location

Institut Curie

Paris, Île-de-France Region, 75248, France

Location

Institut Curie - Hôpital René Huguenin

Saint-Cloud, Île-de-France Region, 92210, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pascale MARIANI, LDD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 29, 2016

Study Start

June 9, 2017

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

Time Frame
Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(3)