Oral Squamous Cell Carcinoma Clinical Trial
Official title:
Validity of Viome's Oral/Throat Cancer Test Among Patients With a Suspicion of Cancer
NCT number | NCT06174428 |
Other study ID # | V303 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2024 |
Est. completion date | December 2026 |
Verified date | April 2024 |
Source | Viome |
Contact | Mory Mehrtash |
Phone | 425-300-6933 |
studies[@]viome.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 2026 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Adults (18 years old or older) - Suspicion of OSCC or OPSCC on clinical presentation by a clinician Exclusion Criteria: - Pregnancy - Use of fertility enhancing medications - Active infection (except for HPV) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Viome |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Primary | Specificity | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Primary | Positive Post Test Probability (PPV) | The probability of having the target condition if the test falls out positive | Through study completion, an average of 18 months | |
Primary | Negative Post Test Probability (NPV) | The probability of having the target condition if the test falls out negative | Through study completion, an average of 18 months | |
Secondary | Sensitivity by care center (primary and secondary) | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by age | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by sex | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by race | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by smoking history | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by oral cancer type (OSCC or OPSCC) | One measure post treatment | Through study completion, an average of 18 months | |
Secondary | Sensitivity by disease stage (I, II, III, and IV) | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by metastasis | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by HPV status | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Sensitivity by recurrent cancer | Oral/Throat cancer test's ability to designate an individual with disease as positive | Through study completion, an average of 18 months | |
Secondary | Specificity by care center (primary and secondary) | One measure post treatment | Through study completion, an average of 18 months | |
Secondary | Specificity by age | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by sex | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by race | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by smoking history | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by oral cancer type (OSCC or OPSCC) | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by disease stage (I, II, III, and IV) | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by metastasis | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by HPV status | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months | |
Secondary | Specificity by recurrent cancer | Oral/Throat cancer test's ability to designate an individual who does not have a disease as negative | Through study completion, an average of 18 months |
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