| CTRI Number |
CTRI/2026/02/104473 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see if cancer is hereditary based on gene sequencing in cases except breast and ovarian cancers |
|
Scientific Title of Study
|
GENE-North: Germline Next-Generation Sequencing to Uncover Pathogenic and Familial Cancer Genes in Solid Cancers (other than Breast and Ovary) in North India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOITRI BASU |
| Designation |
Scientific Officer |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Molecular Laboratory
Lab no. 401, 4th floor, PICU Building
Homi Bhabha Cancer Hospital and Research Centre
Inside SKMCH campus
Umanagar
Muzaffarpur
Muzaffarpur
BIHAR
842004
India |
| Phone |
09831272614 |
| Fax |
|
| Email |
moitrri_basu@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MOITRI BASU |
| Designation |
Scientific Officer |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Molecular Laboratory
Lab no. 401, 4th floor PICU Building
Homi Bhabha Cancer Hospital and Research Centre
Inside SKMCH campus
Umanagar
Muzaffarpur
BIHAR
842004
India |
| Phone |
09831272614 |
| Fax |
|
| Email |
moitrri_basu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
MOITRI BASU |
| Designation |
Scientific Officer |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Molecular Laboratory
Lab no. 401, 4th floor PICU Building
Homi Bhabha Cancer Hospital and Research Centre
Inside SKMCH campus
Umanagar
Muzaffarpur
BIHAR
842004
India |
| Phone |
09831272614 |
| Fax |
|
| Email |
moitrri_basu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Research Administration Council, Dr. E Borges Road, Parel, Mumbai - 400 012 India |
|
|
Primary Sponsor
|
| Name |
TRAC |
| Address |
TATA MEMORIAL CENTRE
Dr. E Borges Road, Parel, Mumbai - 400 012 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Moitri Basu |
Homi Bhabha Cancer Hospital and Research Centre |
Molecular Laboratory, Room No 401. 4th Floor, PICU Building
SKMCH Campus, Uma Nagar, Muzaffarpur
Muzaffarpur
BIHAR |
09831272614
moitrri_basu@yahoo.co.in |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre Varanasi |
1st Floor, Department of Medical Oncology, Mahamana Pandit Madanmohan Malaviya cancer centre, Sundar Bagiya, Near Nariya Gate, Varanasi Hindu University Campus, Varanasi, Uttar Pradesh-221005
Varanasi
UTTAR PRADESH |
7597364554
kapoorakhil1987@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homi Bhabha Cancer Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, MPMMCC Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (3) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (4) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (5) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (6) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (7) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (8) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (9) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (10) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (11) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (12) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (13) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (14) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (15) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (16) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (17) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, (18) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (19) ICD-10 Condition: C7B-C7B||Secondary neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults greater than or equal to 18 years with histologically confirmed solid cancers (non breast and ovary) (all subtypes and all stages) like renal cell carcinoma (RCC), colorectal, endometrial, pancreatic, prostate, thyroid, lung head-neck, rare tumors |
|
| ExclusionCriteria |
| Details |
Inability to consent or inadequate DNA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pathogenic or likely pathogenic prevalence |
After analysis of the sequencing result |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of variants in syndrome-associated versus non-syndromic cancer genes |
After analysis of the sequencing result and getting the clinical information |
| Association of predictors of Pathogenic or likely pathogenic (age less than 45, bilateral/ or multifocal disease, histology, family history) |
After analysis of the sequencing result and getting the clinical information |
| Proportion of variants with potential therapeutic or preventive implications |
After analysis of the sequencing result and getting the clinical information |
|
|
Target Sample Size
|
Total Sample Size="1400"
Sample Size from India="1400"
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)
|
16/03/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In India breast and ovarian cancers have been the primary focus of germline testing but there is a growing body of evidence suggesting a significant hereditary component in other solid tumors such as renal cell carcinoma RCC colorectal endometrial pancreatic prostate thyroid lung head-neck rare tumors and gallbladder cancer GBC.
Renal cell carcinoma RCC and thyroid cancer are both known to have a hereditary component with 3 to 5 percent of RCC and up to 10 percent of differentiated thyroid cancers linked to pathogenic germline variants in cancer predisposition genes. While syndromic causes eg VHL FH FLCN in RCC RET in medullary thyroid carcinoma are well-characterised emerging evidence suggests that a significant proportion of patients even without classical high-risk features harbour pathogenic or likely pathogenic P/LP germline variants particularly in DNA damage response DDR and mismatch repair MMR genes.
Recent Indian data in advanced RCC demonstrate a 20 percent prevalence of germline P/LP variants of which nearly 80 percent would have been missed using conventional testing criteria. Comparable germline data for thyroid cancer in the Indian population are lacking.
Gallbladder cancer is notably more prevalent in the Gangetic belt Uttar Pradesh Bihar and North-East India. Although data is limited familial clustering and early-onset cases suggest potential germline predisposition possibly involving genes like TP53 BRCA1/2 MMR genes STK11 and CDKN2A. This warrants formal exploration.
Understanding the prevalence and spectrum of such variants in unselected patients across all stages is crucial for
Refining genetic testing guidelines relevant to the Indian population.
Identifying at-risk family members through cascade screening.
Exploring therapeutic implications for targeted therapies eg PARP inhibitors ICIs VEGF-TKIs RET inhibitors.
This multicentre study aims to evaluate the prevalence of germline pathogenic or likely pathogenic P/LP variants in unselected patients across a range of non-breast/ovary solid tumors.
Identifying at-risk family members through cascade screening.
Exploring therapeutic implications for targeted therapies eg PARP inhibitors ICIs VEGF-TKIs RET inhibitors.
This multicentre study aims to evaluate the prevalence of germline pathogenic or likely pathogenic P/LP variants in unselected patients across a range of non-breast/ovary solid tumors.
|