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Characterization of Immunosuppressive Signing of Cervical Cancer (Xac03)

Primary Purpose

Cervical Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The women presenting for initial therapeutic management of cervical cancer
  • Elderly patients over 18 years
  • Patients beneficiary of a social security scheme
  • Pregnant women can not participate in this study
  • Women known to be HIV positive will not participate in this study

Exclusion Criteria:

  • Patients with a recurrence of a treaty cervical cancer
  • Patients with a history of pelvic radiotherapy
  • Patients unable to receive informed about the progress and objectives of the study
  • Patients not receiving a social security scheme
  • Patients who have not signed informed consent
  • Immunocompromised patients and pregnant women

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with invasive cervical cancer

Arm Description

Blood sample

Outcomes

Primary Outcome Measures

Lack of tumor emboli histological analysis
Patients with good prognosis of cervical cancer

Secondary Outcome Measures

Full Information

First Posted
August 12, 2016
Last Updated
August 17, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02875990
Brief Title
Characterization of Immunosuppressive Signing of Cervical Cancer
Acronym
Xac03
Official Title
Characterization of Immunosuppressive Signing of Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer. The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with invasive cervical cancer
Arm Type
Experimental
Arm Description
Blood sample
Intervention Type
Biological
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Lack of tumor emboli histological analysis
Description
Patients with good prognosis of cervical cancer
Time Frame
60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The women presenting for initial therapeutic management of cervical cancer Elderly patients over 18 years Patients beneficiary of a social security scheme Pregnant women can not participate in this study Women known to be HIV positive will not participate in this study Exclusion Criteria: Patients with a recurrence of a treaty cervical cancer Patients with a history of pelvic radiotherapy Patients unable to receive informed about the progress and objectives of the study Patients not receiving a social security scheme Patients who have not signed informed consent Immunocompromised patients and pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier CARCOPINO, PU-PH
Email
xavier.carcopino@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Urielle DESALBRES, Director
Phone
04.91.38.27.47
Email
drci@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier CARCOPINO, PU-PH
Email
xavier.carcopino@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Phone
04.91.38.27.47
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Xavier CARCOPINO, PU-PH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Characterization of Immunosuppressive Signing of Cervical Cancer

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