| CTRI Number |
CTRI/2022/11/047056 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
03/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
National Cancer Institute Cancer Awareness Risk assessment and Early detection of Prostate Oral Head Neck Cancers |
|
Scientific Title of Study
|
Screening for risk factors and precancerous lesions of head & neck and prostate cancers in the geographical areas near National Cancer Institute-India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hari Krishna Raju Sagiraju |
| Designation |
Assistant Professor |
| Affiliation |
National Cancer Institute AIIMS |
| Address |
Dept of Preventive Oncology, RMno-3 1st Floor Academic Block, NCI-BADSA
Jhajjar
HARYANA
124105
India |
| Phone |
9599534805 |
| Fax |
|
| Email |
drshkraju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hari Krishna Raju Sagiraju |
| Designation |
Assistant Professor |
| Affiliation |
National Cancer Institute AIIMS |
| Address |
Dept of Preventive Oncology, RMno-3 1st Floor Academic Block, NCI-BADSA
HARYANA
124105
India |
| Phone |
9599534805 |
| Fax |
|
| Email |
drshkraju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hari Krishna Raju Sagiraju |
| Designation |
Assistant Professor |
| Affiliation |
National Cancer Institute AIIMS |
| Address |
Dept of Preventive Oncology, RMno-3 1st Floor Academic Block, NCI-BADSA
HARYANA
124105
India |
| Phone |
9599534805 |
| Fax |
|
| Email |
drshkraju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bayer Pharmaceuticals Pvt. Ltd
Bayer House, Central Avenue, Hiranandani Estate, Thane (West), Maharashtra, India – 400 607 |
|
|
Primary Sponsor
|
| Name |
Bayer Pharmaceuticals Pvt Ltd |
| Address |
Bayer House, Central Avenue, Hiranandani Estate, Thane (West), Maharashtra, India – 400 607 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Hari Krishna Raju Sagiraju |
National Cancer Institute AIIMS |
Dept of Preventive oncology, RMno 3, 1st Floor, Academic block, NCI-BADSA
Jhajjar
HARYANA |
9599534805
drshkraju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults 35 years and above will be enrolled. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults 35 years and above residing in the geographical areas near NCI |
|
| ExclusionCriteria |
| Details |
Those with previous diagnosis of cancer will be excluded.
Those with age<35 years will not be included. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Cancer Risk factors (demographic, metabolic, dietary, lifestyle, smoking/tobacco, pesticide use etc.)
2. Clinical examination findings (BMI, Blood pressure, Heart rate)
3. Clinical measures (HbA1c, Urine albumin & protien, Lipid profile, Hemoglobin etc)
4. PSA (Total & Free) for males above 45 years of age
5.
5. Finding of oral visual examination and oral imaging.
6. Finding of Head & neck clinical examination such as lymph node, thyroid mass/lump.
|
Baseline and annually till end of study period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Cancer Knowledge and attitudes (Cancer awareness & disease perception) |
Baseline and annually till end of study of period. |
|
|
Target Sample Size
|
Total Sample Size="12000"
Sample Size from India="12000"
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)
|
10/11/2022 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this current study, we propose to implement an effective community cancer awarenss, risk factor assessment and early identificaiton of prostate, oral, head/neck cancers program in the geographical areas near NCI-India, using combined approaches of risk factor surveys, point of care testing, mobile health (mhealth) technology to identify individuals at increased risk for these cancers. |