BASE HSP110 : A New Therapeutic Target and a New Marker f... | NCT02458664

Studies
BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer

NCT02458664

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Dec 2, 2015Estimated

Enrollment

597Actual

Phase

Not provided

Conditions

Rectum Cancer
Cancer of Colon

Interventions

Genetic analysis on tumor kept in tumor bank

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A01080-45	Other Grant/Funding Number	N° ID RCB

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

May 27, 2015

First Submission Date that Met QC Criteria

May 28, 2015

First Posted Date

Jun 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection.

We will then be able to evaluate the impact of HSP110, a chaperon protein, on their prognosis. Other proteins (to be determined) will also be study, after.

Detailed Description

To investigate the importance of HSP110DE9 as a prognostic marker for colorectal cancer, we will analyze genotyping fluorescence quantitative RT-PCR and / or immunomarquage the presence of this mutant in a large cohort of patients (more than 2000 patients had or having a colorectal cancer). All patients have been or will be made in general and digestive surgery department at Saint-Antoine hospital. Tumor fragments samples were or will be made on their tumor and keep it in the tumor bank of the Saint-Antoine hospital. All patients reported their no objection to the use of these tumor fragments for research purposes. A database will be built and correlated with the tumor fragments. This project is intended that the constitution of a clinical database including prognostic so that we make discoveries on HSP110DE9 or other molecular biology to discover markers can be correlated with clinical data. In the absence of other studies on the subject, with no real knowledge of the prognostic impact of this mutant, we cannot provide an effective computation. We therefore propose to make a database of 2000 patients retrospectively and prospectively to obtain statistical results valid and powerful.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

597Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colo-rectal cancer		All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital	Genetic: Genetic analysis on tumor kept in tumor bank

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic analysis on tumor kept in tumor bank	Genetic		Colo-rectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence free survival and Recurrence free survival after resection of the colon cancer	3 years for prospective patients, more for retrospective patients	End of follow up : at least 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	3 years for prospective patients, more for retrospective patients	End of follow up : at least 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital.
Patients reporting their non-opposition to the use of tissue samples taken from their specimen for research purposes.

Exclusion Criteria:

Patients who did not report their non-opposition to the use of tissue samples taken from their specimen for research purposes.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients, male or female, over 18 years, undergoing curative colorectal resection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Digestive Surgery, Hôpital Saint-Antoine		Paris	France	75012	France

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided