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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02875990
Other study ID # 2014-03
Secondary ID 2015-A00699-40
Status Not yet recruiting
Phase N/A
First received August 12, 2016
Last updated August 17, 2016
Start date September 2016
Est. completion date September 2024

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact Xavier CARCOPINO, PU-PH
Email xavier.carcopino@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Biological:
Blood sample


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lack of tumor emboli histological analysis Patients with good prognosis of cervical cancer 60 months No
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