CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas (CaptHPV)
Primary Purpose
Cervical Cancer, Vulvar Cancer, Anal Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CaptHPV method
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring HPV infection, Blood sample, Biopsy
Eligibility Criteria
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
Sites / Locations
- Institut de Cancérologie de Lorraine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CaptHPV method
Arm Description
Outcomes
Primary Outcome Measures
Assessement of CaptHPV method
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02981862
First Posted
November 30, 2016
Last Updated
August 25, 2021
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT02981862
Brief Title
CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas
Acronym
CaptHPV
Official Title
Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
June 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer, Penis Cancer
Keywords
HPV infection, Blood sample, Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CaptHPV method
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CaptHPV method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessement of CaptHPV method
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SASTRE-GARAU Xavier, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34108183
Citation
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.
Results Reference
result
Learn more about this trial
CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas
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