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

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.

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Key information

Conditions

Cervical Cancer Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cavity Cancer Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Penile Neoplasms Penis Cancer Pharyngeal Diseases Pharyngeal Neoplasms Rectal Diseases Rectal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CaptHPV method

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: CaptHPV

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Dec 5, 2016
Registry last updated: Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed