| CTRI Number |
CTRI/2021/07/035199 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral Cancer Detection (OC-DETECT) |
|
Scientific Title of Study
|
OC-DETECT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariam Siddiqui |
| Designation |
Manager |
| Affiliation |
RESEARCH TRIANGLE INSTITUTE GLOBAL INDIA PVT LTD (RTI INDIA) |
| Address |
RTI India
6th Floor Commercial Tower of Novotel Pullman Hotel
Aerocity Hospitality District, IGI Airport, New Delhi
South
DELHI
110037
India |
| Phone |
8130736181 |
| Fax |
|
| Email |
msiddiqui@rti.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariam Siddiqui |
| Designation |
Co-Investigator (India PI) |
| Affiliation |
RTI International India |
| Address |
RTI International India
6th Floor, Commercial Tower of Novotel-Pullman Hotel
Aerocity Hospitality District, IGI Airport
South
DELHI
110037
India |
| Phone |
8130736181 |
| Fax |
|
| Email |
msiddiqui@rti.org |
|
Details of Contact Person
Public Query
|
| Name |
Mariam Siddiqui |
| Designation |
Co-Investigator (India PI) |
| Affiliation |
RTI International India |
| Address |
RTI International India
6th Floor, Commercial Tower of Novotel-Pullman Hotel
Aerocity Hospitality District, IGI Airport
South
DELHI
110037
India |
| Phone |
8130736181 |
| Fax |
|
| Email |
msiddiqui@rti.org |
|
|
Source of Monetary or Material Support
|
| National Cancer Institute
31 Center Drive, Building 31, Bethesda, Maryland, 20814
USA |
|
|
Primary Sponsor
|
| Name |
National Cancer Institute |
| Address |
National Cancer Institute
Office of the Director
31 Center Drive, Building 31, Bethesda, Maryland 20814
USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya Parmar |
Indian Cancer Society Delhi |
Indian Cancer Society
Department: Cancer Detection Centre
42 Babar Rd Bengali Market Near Mandi House
New Delhi 110001
Central
DELHI |
9999103457
icsparmar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Cancer Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals at risk for oral cancer, family partners of at risk and oral cancer patients, healthcare providers and community health workers |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (3) ICD-10 Condition: C03||Malignant neoplasm of gum, (4) ICD-10 Condition: C06||Malignant neoplasm of other and unspecified parts of mouth, (5) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (6) ICD-10 Condition: C05||Malignant neoplasm of palate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
OC-DETECT |
OC-DETECT, is a mHealth tool that will be developed to provide a low-cost solution focused on improving education and providing family members with skills to support a home-based screening for early oral cancer detection for at-risk individuals. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals At-Risk or Diagnosed with Oral Cancer
(1) Aged between 40-70 years; (2) at-risk or diagnosed with oral cancer; (3) voluntarily consent; (4) able to understand English or Hindi; (5) currently living in Delhi; and (6) currently COVID negative.
Family Members of Individuals Diagnosed with Oral Cancer
(1) Ages between 16-30 years; (2) own a smartphone; (3) voluntarily consent; (4) be able to read and understand English or Hindi; (5) have a family member at-risk for oral cancer or already diagnosed with oral cancer, (6) currently living in Delhi; and (6) currently COVID negative.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility of OC-DETECT for use by family members, and the ability to collect quality oral cavity images. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in oral cancer prevention and detection knowledge. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We propose to develop an innovative platform called Oral Cancer Detect (OC-DETECT) that will leverage secure, cloud-based technology for individuals that supports on-demand education, early detection, referral, and linkage to care (LTC) through integrated technology with e-screening, micro-learning educational content, motivational messaging, and e-referrals. The specific aims for the OC-DETECT research are to: (1) Use formative research with individuals at risk for oral cancer and their family members, health care providers (HCPs), community health workers (CHWs), and relevant stakeholders to identify the needs and requirements for identifying oral cancer and improving LTC; (2) Build the OC-DETECT prototype to deliver education, e-screening, referral, and LTC on mobile devices; (3) Evaluate with 20 dyads (an individual at risk of oral cancer and a family partner) in pilot testing the feasibility of using OC-DETECT to increase the frequency of screening, referrals, and awareness of oral cancer. We hypothesize that it will be feasible for OC-DETECT to provide mHealth services (education, screening, referral, and LTC) for individuals at risk for oral cancer outside a clinic setting. Overall, we will conduct formative research (i.e., e-surveys, in-depth interviews, focus group discussions) and pilot testing the feasibility of using OC-DETECT. This is at best an observational study with no deviation from the standard of care. |