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

Cervical Cancer Clinical Trial

— CaptHPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981862
• Other study ID #: 2016-A01085-46
• Status: Completed
• Phase: N/A
• Start date: December 19, 2016
• Est. completion date: June 12, 2018

Study information

• Verified date: August 2021
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Cervical Cancer
• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Penile Neoplasms
• Penis Cancer
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Invas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day