Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers (HPV OncoTect™)

July 20, 2018 updated by: Gustave Roussy, Cancer Campus, Grand Paris
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

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:

  1. Untreated oropharynx epidermoid carcinoma
  2. Patient ≥ 18 years old
  3. Patient affiliated to a social security scheme or beneficiary of such a scheme
  4. Information to the patient or his legal representative and signature of informed consent

Exclusion Criteria:

  1. Non-oropharyngeal epidermoid carcinoma
  2. Oropharyngeal epidermoid carcinoma previously treated

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
OTHER: Patients with oropharyngeal cancer

Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.

Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.
Diagnostic test: HPV OncoTect™

Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.

Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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)

January 17, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (ACTUAL)

July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01655-46
  • 2016/2474 (OTHER: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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