CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas

NCT ID: NCT02981862

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-19

Study Completion Date

2018-06-12

Brief Summary

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The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.

Detailed Description

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Conditions

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Cervical Cancer Vulvar Cancer Anal Cancer Oropharynx Cancer Oral Cavity Cancer Penis Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CaptHPV method

Group Type EXPERIMENTAL

CaptHPV method

Intervention Type OTHER

20 ml of blood sample will be made before the beginning of all treatment. This blood sample will be sent to the CERBA Laboratory for analysis.

In parallel, a standard anatomopathological and virological analysis will be carried out from a biopsy or from a tumor sample by the Tumor Biology Unit at Lorraine Institute of Oncology

The results of both analyzes will be compared blindly.

Interventions

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CaptHPV method

20 ml of blood sample will be made before the beginning of all treatment. This blood sample will be sent to the CERBA Laboratory for analysis.

In parallel, a standard anatomopathological and virological analysis will be carried out from a biopsy or from a tumor sample by the Tumor Biology Unit at Lorraine Institute of Oncology

The results of both analyzes will be compared blindly.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Patient with cervical cancer, vulvar cancer, anal cancer, oropharynx cancer, oral cavity cancer or penis cancer
* Patient naive of any treatment for this pathology
* Patient capable and willing to follow all procedures of the study in accordance with the study
* Ability to provide an informed written consent form
* Affiliation to a social security system

Exclusion Criteria

* Patients who have already undergone surgical treatment leading to complete removal of the lesions or who have started treatment with radiotherapy and / or chemotherapy
* Patient whose health status contraindicates a blood sample of 20 ml,
* Absence of informed written consent form
* Pregnant or breast feeding females
* Patients deprived of liberty or under supervision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SASTRE-GARAU Xavier, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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Sastre-Garau X, Diop M, Martin F, Dolivet G, Marchal F, Charra-Brunaud C, Peiffert D, Leufflen L, Dembele B, Demange J, Tosti P, Thomas J, Leroux A, Merlin JL, Diop-Ndiaye H, Costa JM, Salleron J, Harle A. A NGS-based Blood Test For the Diagnosis of Invasive HPV-associated Carcinomas with Extensive Viral Genomic Characterization. Clin Cancer Res. 2021 Oct 1;27(19):5307-5316. doi: 10.1158/1078-0432.CCR-21-0293.

Reference Type RESULT
PMID: 34108183 (View on PubMed)

Other Identifiers

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2016-A01085-46

Identifier Type: -

Identifier Source: org_study_id

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