4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Clinical and Biological Database in Colon Cancer and Colic Tumors (BCBCOLON)

Clinical and Biological Database in Colon Cancer and Colic Tumors (BCBCOLON)

Study Description
Brief Summary:
Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

Condition or disease Intervention/treatment Phase
Cancer Colon Other: Biological collection Not Applicable

Detailed Description:

As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2030
Arms and Interventions
Arm Intervention/treatment
Experimental: Biological collection

For all the patients include in the study :

samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections.

In parallel to this biological collection, standardized clinical data will be entered into a database

 Other: Biological collection
The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.
Outcome Measures
Primary Outcome Measures :
  1. Number of clinical risk factors for colorectal cancer [ Time Frame: Until the study completion : 6 years ]
  2. Number of biological risk factors for colorectal cancer [ Time Frame: Until the study completion : 6 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
  2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
  3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
  4. Patient with familial polyposis eligible for colectomy
  5. Age > 18 years
  6. Signed informed consent

Exclusion Criteria:

  1. Patient not affiliated to Social Protection system
  2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  3. Patient under guardianship
  4. Minor patient
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jean-Pierre BLEUSE, M.D 4 67 61 31 02 ext + 33 DRCI-icm105@icm.unicancer.fr

Locations
Layout table for location information
France
CHRU de Montpellier Recruiting
Montpellier, Hérault, France, 34298
Contact: Eric Assénat, MD    467330137 ext +33    e-assenat@chu-montpellier.fr   
Institut Régional du cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: ERIC ASSENAT, MD         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: ERIC ASSENAT, M.D Institut régional du cancer de Montpellier
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Number of clinical risk factors for colorectal cancer [ Time Frame: Until the study completion : 6 years ]
  • Number of biological risk factors for colorectal cancer [ Time Frame: Until the study completion : 6 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Proportion of patients who gave their consent to participate in the study [ Time Frame: Until the study completion : 6 years ]
The proportion of patients who consent to participate in the study among the screened patients
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Biological Database in Colon Cancer and Colic Tumors
Official Title  ICMJE Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
Brief Summary Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.
Detailed Description

As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cancer Colon
Intervention  ICMJE Other: Biological collection
The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.
Study Arms  ICMJE Experimental: Biological collection

For all the patients include in the study :

samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections.

In parallel to this biological collection, standardized clinical data will be entered into a database

Intervention: Other: Biological collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2030
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
  2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
  3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
  4. Patient with familial polyposis eligible for colectomy
  5. Age > 18 years
  6. Signed informed consent

Exclusion Criteria:

  1. Patient not affiliated to Social Protection system
  2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  3. Patient under guardianship
  4. Minor patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Pierre BLEUSE, M.D 4 67 61 31 02 ext + 33 DRCI-icm105@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976960
Other Study ID Numbers  ICMJE BCB2014/01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: ERIC ASSENAT, M.D Institut régional du cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯