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

Monocentric Study of Validation of the Method CaptHPV for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02981862

Acronym

CaptHPV

Enrollment

100

Registered

2016-12-05

Start date

2016-12-19

Completion date

2018-06-12

Last updated

2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HPV infection, Blood sample, Biopsy

Brief summary

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.

Interventions

OTHERCaptHPV 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessement of CaptHPV method	1 day	The diagnostic value of the serum marker provided by the method CaptHPV will be assessed in sensitivity and specificity to results of histological and virological analyzes of a sample tumor.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026