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Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Study Purpose

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for participants in OSCC or OPC cohorts.

  • - Participants must be diagnosed with oral squamous cell carcinoma (OSCC) and/or OroPharyngeal cancer (OPC) - Aged 18 years or older.
  • - Signed and dated informed consent prior to any study-specific procedures are performed.
  • - Willing and able to follow the study instructions, as described in the recruitment letter.
Exclusion Criteria for participants in OSCC or OPC cohorts.
  • - Pregnancy.
  • - Use of fertility enhancing medications.
  • - Active infection.
Inclusion Criteria for participants in OPMD cohorts.
  • - Any Oral Premalignant Disorder (OPMD) - Dysplasia.
  • - Hyperplasia.
  • - Leukoplakia.
  • - Erythroplasia.
  • - Lichenoid lesions.
  • - Actinic Keratosis.
  • - Lichenoid reaction.
  • - Aphthous ulcer/ Canker Sores.
  • - Gingival enlargement (side effect) - Lichen planus.
  • - Keratosis.
  • - Inflammatory reaction.
  • - Cheek bites.
  • - Aged ≥50 years OR aged 18 years or older with a history of tobacco use (see above) - Signed and dated informed consent prior to any study-specific procedures are performed.
  • - Willing and able to follow the study instructions, as described in the recruitment letter.
Exclusion Criteria for participants in OPMD cohorts.
  • - Pregnancy.
  • - Use of fertility enhancing medications.
  • - Active infection.
Inclusion Criteria for participants in cancer-free cohorts.
  • - Aged ≥ 50 years OR aged 18 years or older with a history of tobacco use.
  • - Signed and dated informed consent prior to any study-specific procedures are performed.
  • - Willing and able to follow the study instructions, as described in the recruitment letter.
Exclusion criteria for participants in cancer-free cohorts.
  • - Pregnancy.
  • - Use of fertility enhancing medications.
- Active infection

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05451303
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Viome
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Cristina Julian, PhD
Principal Investigator Affiliation Viome
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Oral Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Premalignant Lesion
Additional Details

This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic. A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities. Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Arms & Interventions

Arms

: Oral Squamous Cell Carcinoma (OSCC)

OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.

: OroPharyngeal Cancer (OPC)

OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.

: Oral Potentially Malignant Disease (OPMD)

OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to: Dysplasia Hyperplasia Leukoplakia Erythroplasia Lichenoid lesions Actinic Keratosis Lichenoid reaction Aphthous ulcer/ Canker Sores Gingival enlargement (side effect) Lichen planus Keratosis Inflammatory reaction Cheek bites

: Cancer-free

Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.

Interventions

Device: - OralViome Cancer Testing System

The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYMC, New York, New York

Status

Recruiting

Address

NYMC

New York, New York, 10595

Site Contact

Gavin Hougham, PhD

[email protected]

914-594-4892

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