An interventional study of Biopsy in Rectum Adenocarcinoma, sponsored by Institut Curie. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by Institut Curie · Not applicable, Interventional, and Diagnostic
Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.
Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's enrollment of 14 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Rectoscopy with biopsy
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)
Time frame: 3 years
Study of fibroblast impact on colorectal tumor cells (in vitro)
In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).
Time frame: 3 years
Metastatic spread evaluation
On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth
Time frame: 3 years
Outcomes 1 to 3 correlation with histological response after RT-CT
Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997
Time frame: 3 years
Disease-free survival
Disease-free Survival assessment
Time frame: 5 years
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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