NCT02981862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

December 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

November 30, 2016

Last Update Submit

August 25, 2021

Conditions

Cervical CancerVulvar CancerAnal CancerOropharynx CancerOral Cavity CancerPenis Cancer

Keywords

HPV infectionBlood sampleBiopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

CaptHPV method

EXPERIMENTAL
Other: CaptHPV method

Interventions

CaptHPV methodOTHER

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.

CaptHPV method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related 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 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.

    PMID: 34108183RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsVulvar NeoplasmsAnus NeoplasmsOropharyngeal NeoplasmsMouth NeoplasmsPenile NeoplasmsPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVulvar DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesMale Urogenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • SASTRE-GARAU Xavier, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

December 19, 2016

Primary Completion

June 12, 2018

Study Completion

June 12, 2018

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)