| CTRI Number |
CTRI/2026/01/102387 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Genetic Screening in Family-Related Gynecological Cancers |
|
Scientific Title of Study
|
Genetic Screening in Familial Gynaecological Cancers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shyamala G |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal MAHE Manipal |
| Address |
women and child block , Ground floor , department of obstetrics and genecology , Kasturba medical college Manipal .
Udupi
KARNATAKA
576104
India |
| Phone |
9424578444 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shyamala G |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal MAHE Manipal |
| Address |
women and child block , Ground floor , secretary office , department of obstetrics and genecology , Kasturba medical college Manipal .
Udupi
KARNATAKA
576104
India |
| Phone |
9424578444 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Avisha Malu |
| Designation |
Dr. |
| Affiliation |
Kasturba Medical College Manipal MAHE Manipal |
| Address |
women and child block , Ground floor , secretary office , department of obstetrics and genecology , Kasturba medical college Manipal .
Udupi
KARNATAKA
576104
India |
| Phone |
9424578444 |
| Fax |
|
| Email |
maluavisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital , Manipal , Udupi , Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shyamala G |
Kasturba Medical Hospital |
room no . 7,gynecological opd , department of obstetrics and gynecology, women and child block, KMC hospital, Manipal , Karnataka , India
Udupi
KARNATAKA |
9844551037
shyamala.g@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
strong family history of genetic familial gynecological cancers |
| Patients |
(1) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Women above the age of 18 years, diagnosed with ovarian or endometrial cancer.
Individuals with a strong family history of gynecologic cancers. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Individuals with severe psychiatric conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowing the gene mutation will direct the cancer treatment for you. It will also help in identifying other family members at risk and help them consider risk reducing measures. |
6 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Acceptance rate of genetic screening.
Percentage of positive & negative genetic tests.
Psychological impact & decision regret.
Compliance with preventive measures. |
1 year & 2 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/02/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study will involve around [150] participants diagnosed with ovarian or endometrial cancer. We will collect detailed three- generation pedigree history of familial gynecologic cancers and offer appropriate genetic testing. Women willing for the same will undergo genetic screening. We will administer detailed questionnaire to the test-acceptors and non-acceptors to find out the reasons for the decisions. At one-year follow up, we will administer another questionnaire to assess psychological and social impacts of the results. |