Oral Squamous Cell CarcinomaNCT01587573
Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer
An observational study of Oral Squamous Cell Carcinoma, run by PeriRx at 5 sites in United States.
Trial summary
The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- saliva collection prior to clinically driven oral biopsy
- Type of treatment
- Pill or oral medicine
- How many people
- 370 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2012to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy
Who may be able to join
- Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer
Who cannot join
- Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 2 recruiting
- Terminated
University of Michigan
Ann Arbor, Michigan, 48109
- Withdrawn
University of Illinois at Chicago
Chicago, Illinois, 60612
- Terminated
Department of Surgery, Michigan Sate University
East Lansing, Michigan, 48912
- Recruiting
St. John Providence Health System
Warren, Michigan, 48092
Michael Shaw, PhD, 248-967-7791, Michael.Shaw@providence-stjohnhealth.org
Harvey Zalesin, DDS
- Recruiting
Main Line Health System
Wynnewood, Pennsylvania, 19096
Marc Surkin, MD, 610-446-6900
About this study
Official title: Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma
The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.
Read the detailed description
Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- saliva collection prior to clinically driven oral biopsy
- Keywords
- salivary biomarkers
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva collection prior to clinically driven oral biopsyOther
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA
| Study group | Role | What they receive |
|---|---|---|
| oral lesions | oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy Receives: Other: saliva collection prior to clinically driven oral biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test specificity at 90% sensitivity
Based on multimarker test score
Measured: at study completion as well as after model development following enrollment of the first 30 patents with cancer
Secondary outcomes (2)
Validation of individual mRNA and protein markers
Based on comparison of cancer and controls
Measured: After enrollment of 30 patients with cancer
Validation of a pre-specified multi marker model
Based on combined sensitivity and specificity
Measured: After enrollment of 30 patients with cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeriRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack L Martin, MD, Principal investigator, PeriRx, LLCMarc Surkin, MD, Study chair, Main Line Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587573
- Sponsor's protocol ID
- PeriRx-1
- Status last verified
- May 2017
- First submitted
- 26 Apr 2012
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Martin JL. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort. PLoS One. 2016 Jul 13;11(7):e0158462. doi: 10.1371/journal.pone.0158462. eCollection 2016.
PubMed 27411053
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01587573
- Acronym / sponsor ID
- PeriRx-1
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- salivary biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- PeriRxIndustry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.
Detailed description
Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral lesions | – | Other: saliva collection prior to clinically driven oral biopsyoral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy
Key inclusion criteria (1 listed)
- Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer
Key exclusion criteria (1 listed)
- Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva collection prior to clinically driven oral biopsycell free saliva to be used to measure mRNA and proteins by PCR and ELISA | Other | oral lesions |
Primary outcome
Test specificity at 90% sensitivity
Time frame: at study completion as well as after model development following enrollment of the first 30 patents with cancer
Based on multimarker test score
2 secondary outcomes
Validation of individual mRNA and protein markers
Time frame: After enrollment of 30 patients with cancer
Validation of a pre-specified multi marker model
Time frame: After enrollment of 30 patients with cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 27411053Martin JL. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort. PLoS One. 2016 Jul 13;11(7):e0158462. doi: 10.1371/journal.pone.0158462. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
St. John Providence Health System
Warren, United States
Jack L Martin, MD principal investigator
PeriRx, LLC
Marc Surkin, MD study chair
Main Line Health System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma, run by PeriRx at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test specificity at 90% sensitivity (time frame: at study completion as well as after model development following enrollment of the first 30 patents with cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.