NCT02875990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

8 years

First QC Date

August 12, 2016

Last Update Submit

August 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lack of tumor emboli histological analysis

    Patients with good prognosis of cervical cancer

    60 months

Study Arms (1)

patients with invasive cervical cancer

EXPERIMENTAL

Blood sample

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL
patients with invasive cervical cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Xavier CARCOPINO, PU-PH

CONTACT

Urielle DESALBRES, Director

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 23, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations