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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Other | Rectoscopy with biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Study of fibroblast impact on colorectal tumor cells (in vitro) | In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metastatic spread evaluation | On a mouse model of orthotopic rectal cancer, assessment of the potential and metastatic tumor growth | 3 years |
| Outcomes 1 to 3 correlation with histological response after RT-CT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascale MARIANI, LDD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSTITUT CURIE - Site Paris | Paris | 75005 | France | |||
| Institut Curie |
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.
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Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
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).
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Histological response after RT-CT assessed according to the tumor regression grading - Dworak 1997
| 3 years |
| Disease-free survival | Disease-free Survival assessment | 5 years |
| Paris |
| Île-de-France Region |
| 75248 |
| France |
| Institut Curie - Hôpital René Huguenin | Saint-Cloud | Île-de-France Region | 92210 | France |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |