| CTRI Number |
CTRI/2024/06/068640 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Expression of a gene mutation study in breast cancer |
|
Scientific Title of Study
|
Expression of methylenetetrahydrofolate reductase (MTHFR) C677T gene polymorphism in breast cancer: A case control study |
| 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 Shaad Vali |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
7069315615 |
| Fax |
|
| Email |
valishaad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Tomar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9711972630 |
| Fax |
|
| Email |
drreenat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Tomar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9711972630 |
| Fax |
|
| Email |
drreenat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg, New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi - 110002 |
| 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 Shaad Vali |
Maulana Azad Medical College |
Room no. 54, Department of Pathology, Pathology Block, 2 Bahadur Shah Zafar Marg
Central
DELHI |
7069315615
valishaad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.I.P.M.E.R., Guru Nanak Eye Centre, New Delhi - 110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
For cases: Newly diagnosed and histopathologically confirmed cases of invasive ductal carcinoma of breast (IDC); no special type (NST) in female patients presenting with palpable breast lump.
For controls: Diseased women brought in for postmortem examination with no past history of breast cancer. |
|
| ExclusionCriteria |
| Details |
For cases: 1. Patients who have received radiotherapy, chemotherapy and/or immunotherapy 2. Former history of breast cancer or any other types of cancer
For controls: 1. Decomposed/ decayed body 2. Former history of breast cancer or any other types of cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of expression of methylenetetrahydrofolate reductase (MTHFR) C677T gene polymorphism in case and control population |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of expression of methylenetetrahydrofolate reductase (MTHFR) C677T gene polymorphism in breast cancer patients and their association with histological grade and proliferation index |
Baseline |
|
|
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)
|
01/07/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Primary purpose: To study expression of Methylenetetrahydrofolate Reductase (MTHFR) C677T gene polymorphism in breast cancer and study its association with histological grade and proliferation index of breast cancer. Breast cancer, the most common malignancy affecting women worldwide, remains a significant cause of cancer-related deaths. While the precise mechanisms of breast carcinogenesis are not fully understood, it is established that genetic factors interact with environmental influences, determining
individual susceptibility. This study focuses on the Methylenetetrahydrofolate reductase gene (MTHFR) and its association with breast cancer. Specifically, the functional single-nucleotide polymorphism (SNP) C677T in the MTHFR gene may impact tumor cell chemosensitivity. The MTHFR enzyme,
crucial for intracellular folate homeostasis, catalyzes the conversion of 5,10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, which serves as a carbon donor for homocysteine methylation to methionine. Additionally, MTHFR plays a vital role in DNA biosynthesis, repair, and maintenance of
DNA stability |