| CTRI Number |
CTRI/2019/01/016924 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
20/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Onc-Alert - A Saliva-based detection test for oral cancer |
|
Scientific Title of Study
|
A prospective, pilot evaluation of a point of care saliva-based detection test based on soluble CD44 (OncAlert) for the presence of disease in a previously untreated oral cavity and oropharynx squamous cell carcinoma. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3154 Version 1.1 dated 04-Oct-2018 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir V Nair |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM NO 1206
HBB
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177283 |
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir V Nair |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM NO 1206
HBB
Tata Memorial Hospital
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177283 |
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir V Nair |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM NO 1206
HBB
Tata Memorial Hospital
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177283 |
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Trusts
BOMBAY HOUSE HOMI MODY STREET
MUMBAI - 400 001
TEL 66668282 |
| Vigilant Biosciences
6301 NW 5th Way Suite 1500
Fort Lauderdale FL 33309
USA |
|
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Primary Sponsor
|
| Name |
Vigilant Biosciences |
| Address |
6301 NW 5th Way Suite 1500 Fort Lauderdale FL33309
USA |
| Type of Sponsor |
Other [Foriegn Biotechnology Company] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Nair |
Tata Memorial Centre |
Dr. E Borges Road Parel
Mumbai 400 012
India
Mumbai
MAHARASHTRA |
02224177283
sudhirvr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE II |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FREE OF ORAL / OROPHARYNGEAL CANCER |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (3) ICD-10 Condition: C03||Malignant neoplasm of gum, |
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects must meet all of the inclusion criteria to participate in this study.
1) Patient has the ability to understand and the willingness to sign a written informed consent.
2) Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0
3) No prior history of treated upper aerodigestive tract cancer
4) No concurrent, second, active malignancy other than the oral cavity and/or oropharynx cancer
5) Planned to undergo treatment with curative intent
6) Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post-treatment follow up
7) For control subjects: no evidence or history of upper aerodigestive tract cancer
8) For control subjects: absence of any suspected or confirmed active malignancy at the time of enrollment.
9) Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy
10) The patient or the healthy volunteer is more than or equal to 18 years of age.
11) Performance Status less than or equal to ECOG 3
12) The patient is able to gargle and spit 5 cc of saline
13) Patients may be concurrently enrolled in other therapeutic or detection clinical trials.
|
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| ExclusionCriteria |
| Details |
1) Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years.
2) Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy
3) Patient unable or does not intend to undergo curative therapy
4) Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment.
5) Non-squamous histology
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The sensitivity and specificity to detect OOPSCC in cases compared to a non-cancer control population. We anticipate that the POC test renders a sensitivity of at least 80% which is much higher than what is currently available, and therefore we consider a specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen. |
At the completion of the study - 24 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. The association of salivary test biomarkers with clinical characteristics of OOPSCC patients and patient overall and disease-free survival using univariate and multivariate analyses.
2. The association of post-treatment SolCD44 and Total Protein with recurrence and determine the magnitude of that association.
3. Preliminary estimates of possible lead time if SolCD44 / Total Protein elevation precedes recurrence.
|
At the completion of the study - 24 months
|
|
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Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
The study may be published in a peer reviewed journal upon completion of all study related activity |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Oral and oropharyngeal cancer is a significant health issue and has high mortality and morbidity: Squamous cell carcinomas, including those of the mouth and oropharynx, comprise more than 90% of all cancers affecting these tissues. The main risk factors include tobacco and alcohol use, and human papillomavirus (HPV) infection . The incidence of these cancers is rising with the increasing incidence of HPV+ oropharyngeal cancer. Of all the major cancers, oral and oropharyngeal cancer has one of the worst five-year survival rates at 62.7%. Improved diagnosis of OOPSCC is an unmet need. The current “gold standard†for OOPSCC diagnosis is a physical and visual examination followed by biopsy. . Unfortunately, most oral cancer cases are diagnosed in late stage (III or IV) with a five-year survival rate around 30-40% even after aggressive treatment regimens including combinations of radiation, surgery and chemotherapy.
A survey conducted by the ADA revealed that only 16% of patients reported having an oral cancer examination during a routine dental appointment or were unaware that the screening had been performed. Oropharyngeal cancer is even more difficult to diagnose, as the lymphoid tissue in the oropharynx from which these tumors arise often cannot be visualized well and is difficult to distinguish from tumor. As a result, over 90% of oropharyngeal cancers are diagnosed at a late stage. However, if diagnosed early (stage I/II), the five-year survival-rate can be as high as 80-90% for oral cancer cases and HPV- oropharynx cancers. A shift to improved diagnosis of oral cavity and oropharynx cancers would result in a significant healthcare cost savings.
Previous studies have shown that a laboratory-based test comprising a CD44 ELISA and Lowry-like protein assay has an estimated sensitivity of 80% and specificity of 93% for distinguishing OOPSCC from high-risk controls. High SolCD44 levels are independently associated with poor PFS and OS (below). The laboratory-based test for SolCD44 (Vigilant Bioscience’s OncAlert test ) has been converted to a convenient point of care product and may provide a very simple and inexpensive method to determine those at risk for OOPSCC cancer.
This study will generate preliminary data in Indian patient cohort. It will study the sensitivity and specificity of the test kit in detecting oral cancers in patients with known oral or oropharyngeal cancers as well as in healthy volunteers. Since the test is done on salivary rinse, this is a non-invasive test and all patients with oral/oropharyngeal cancers are managed at the Tata Memorial Hospital. The healthy volunteers will undergo a free clinical evaluation to rule out pre-existing oral /oropharyngeal cancers before recruiting them in the study.
A successful outcome of this study will give us a convenient point of care device to detect oral cancers with good sensitivity and specificity. This will be used by dentists as well as other health care workers and will be of great help in screening high-risk population.
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