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

August 25, 2021 updated by: Institut de Cancérologie de Lorraine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CaptHPV method
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessement of CaptHPV method
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: SASTRE-GARAU Xavier, MD, Institut de Cancérologie de Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2016

Primary Completion (ACTUAL)

June 12, 2018

Study Completion (ACTUAL)

June 12, 2018

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (ESTIMATE)

December 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01085-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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