| CTRI Number |
CTRI/2025/09/094960 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic Polymorphism and Methotrexate Toxicities |
|
Scientific Title of Study
|
A Prospective Observational Study to Determine the Association of Genetic Polymorphisms with Serum Methotrexate Levels in Cancer Patients with Methotrexate Related Toxicities |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhartha Krishna Deka |
| Designation |
DM Resident |
| Affiliation |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9435400798 |
| Fax |
|
| Email |
sidd38.skd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Prabhakar Reddy |
| Designation |
Professor |
| Affiliation |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
7416512888 |
| Fax |
|
| Email |
cptnims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Prabhakar Reddy |
| Designation |
Professor |
| Affiliation |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
7416512888 |
| Fax |
|
| Email |
cptnims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, PIN- 500082, India |
|
|
Primary Sponsor
|
| Name |
Siddhartha Krishna Deka |
| Address |
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, PIN- 500082, India |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Siddhartha Krishna Deka |
Nizams Institute of Medical Sciences, Hyderabad |
Department of Clinical Pharmacology & Therapeutics and Department of Medical Oncology, Nizam’s Institute of Medical Sciences, Hyderabad
Hyderabad
TELANGANA |
9435400798
sidd38.skd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with various cancers undergoing MTX chemotherapy, receiving Methotrexate at a dose of more than 500 mg
2. Age: Above 18 years and less than 65 years
3. Gender: Male and Female
4. Those who are willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation.
2. History of a drug reaction or allergy to Methotrexate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients with C677T and A1298C MTHFR Genetic polymorphism in cases of Methotrexate toxicity as well as in controls (Grade 0).
2. Correlation of C677T and A1298C MTHFR Genetic Polymorphism with Serum Levels of Methotrexate.
|
24, 48, and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The correlation between genetic polymorphism and hematologic and non-hematologic toxicities. |
24, 48, and 72 hours |
|
|
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)
|
01/10/2025 |
| 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="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
|
|
Methotrexate (MTX)
is frequently used to treat several illnesses, including inflammatory bowel
disease, rheumatoid arthritis, psoriasis, cancer, acute lymphoblastic
leukaemia or lymphoma, and hematopoietic cell transplantation. Methotrexate
has been shown to inhibit Methylene tetrahydrofolate reductase (MTHFR). The
intestinal epithelium and bone marrow are the main targets of MTX toxicity. Elevation
of transaminases could indicate hepatic toxicity, increasing the risk of
cirrhosis. MTX can also cause alopecia, dermatitis, allergic interstitial
pneumonitis, neurologic symptoms, changes in bone metabolism,
hyperhomocysteinemia, nephrotoxicity (after high-dose treatment), abortion,
teratogenesis, impaired oogenesis or spermatogenesis. Two genetic variations
can lower MTHFR’s enzyme function, namely, rs1801133 (C677T) and
rs1801131 (A1298C).
Therefore, this
study is being planned in the South Indian Population to determine the serum
concentrations of Methotrexate and the genetic polymorphisms associated with
it, in oncology patients receiving Methotrexate chemotherapy and presenting
with toxicity.
The study aims to
investigate the influence of genetic polymorphisms on serum concentrations of
Methotrexate, methotrexate induced toxicities in cancer patients receiving
Methotrexate chemotherapy.
|
|