| CTRI Number |
CTRI/2025/09/094258 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
In women with uterine cancer whether the pre-test genetic counselling improves the genetic testing rate in patients and their relatives |
|
Scientific Title of Study
|
Evaluation of impact of pre-test counselling on uptake of germline testing and assessment on barriers to genetic testing in women with endometrial cancer and her first-degree relatives |
| 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 Sarita Singh |
| Designation |
Senior Resident |
| Affiliation |
AIIMS DELHI |
| Address |
Dept of Obst and Gyane
Anasri Nagar
South
DELHI
110029
India |
| Phone |
26588500 |
| Fax |
|
| Email |
saritasingh_og@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS DELHI |
| Address |
Dept of Obst and Gyane
Ansari Nagar
South
DELHI
110029
India |
| Phone |
1126588500 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS DELHI |
| Address |
Dept of Obst and Gyane
Ansari Nagar
South
DELHI
110029
India |
| Phone |
1126588500 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS DELHI |
| Address |
AIIMS, Sri Aurobindo Marg, Ansari Nagar East, India, Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Sarita Singh |
AIIMS DELHI |
Dept of Obstetrics and Gyanecology, and Gyane cancer clinics
Room no 5
Maternal and Child Health Bloc
Ansari Nagar East
Delhi 110029
South
DELHI |
01126588500
saritasingh_og@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE FOR POST GRADUATE RESEASCH AIIMS DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Women diagnosed with endometrial cancer having deficient mismatch repair (dMMR) on immuno-histochemistry (IHC).
2.Women diagnosed with endometrial cancer meeting the criteria for testing for Lynch Syndrome according to the NCCN criteria version 4.2024.
3. Women with endometrial cancer having an increased risk (more than or equal to 2.5 percent) of Lynch Syndrome as predicted by the PREMM5 risk prediction model.
4.Patients and first-degree relatives capable of providing informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Women and first-degree relatives with diagnosed psychiatric illness currently under treatment
2.First-degree relatives with age less than 18years.
3.Not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•The proportion of women with endometrial cancer undergoing genetic counselling and, subsequently, germline testing.
•The proportion of first-degree relatives who are willing to undergo genetic counselling and subsequently agree to germline testing.
•The number of cases tested positive for Lynch-related mutations.
•The number of women who refuse to undergo genetic testing and the reasons for it.
•Number of FDRs who agree to undertake genetic counselling.
•Number of FDRs who undergo genetic testing after genetic counselling.
|
0 and 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Comparison of Stress, Anxiety, and Depression (DASS) 21 score at the time of genetic counselling and at 3 months of genetic counselling in women with endometrial cancer. |
0 and 3months |
| • Evaluation of Satisfaction with the decision of the women with endometrial cancer at three months of genetic counselling by satisfaction with decision score (SWD score). |
3month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/09/2025 |
| 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 |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - by e-mail to study investigators
saritasingh_og@yahoo.co.in
- For how long will this data be available start date provided 01-07-2028 and end date provided 30-06-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Women with endometrial cancer who satisfy the inclusion and exclusion criteria will be recruited after the written consent is obtained. The retrospective cohort will be recruited by screening the data of endometrial cancer patients enrolled at gynaecology and hereditary cancer clinics from January 2020 to June 2025. The women with endometrial cancer having deficient mis-match repair (dMMR on immunohistochemistry (IHC) and women with pMMR who are satisfying NCCN Version 4.2024 and/or PREMM 5 algorithm will be contacted telephonically and invited for genetic counselling. The prospective cohort will be included from July 2025, and endometrial cancer patients with dMMR positivity and women with pMMR who are satisfying NCCN Version 4.2024 and/or PREMM 5 algorithm will be enrolled in the study after the consent. The study objectives will be explained in detail at the time of genetic counselling, and after obtaining written consent, they will be included in the study. A detailed history will be taken, including demographic details, presenting complaints, menstrual history, obstetric history, and other gynaecological history, and details of any significant medical, surgical, or family history or personal and family history of malignancy. Each participant will be given an appointment for their Genetic counselling session after consent. The study researcher will do the genetic counselling session, and the patient may be alone or accompanied by an attendant during the session. The genetic counselling session is described briefly below. After the conclusion of the genetic counselling session, participants’ Stress, Anxiety, and Depression (DASS-21) scores will be evaluated. Additionally, a questionnaire will be administered to document their reasons for accepting or declining genetic testing. The DASS-21 score will be reassessed three months after the counselling session, and satisfaction with decision score (SWD) will be calculated three months after the s session. Those women undergoing germline testing will undergo detailed post-test counselling, which will include implications of having positive/negative/inconclusive test on their future prognosis, treatment and the effect it has on their families. The patients with favorable pathogenic germline mutations will be explained in detail about the increased risk of malignancies in their first-degree relatives (FDRs) and will be requested to be informed about the need for genetic counselling and testing. The women who refuse to undergo testing will be evaluated for barriers through a questionnaire. The proportion of first-degree relatives who accept genetic counselling will be documented in the study proforma. Those who consent to counselling will also be given the scheduled appointment for a genetic counselling session, and the study researchers will also counsel them. Subsequently, post-genetic counselling regarding the necessity for germline testing will be explained, and the testing uptake will be recorded. The barriers to germline testing will be assessed for FDRs by the questionnaire. |