| CTRI Number |
CTRI/2026/03/106558 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess how genetic differences (UGT1A1 gene variation) affect the safety of irinotecan treatment in cancer patients at a tertiary care hospital in South India. |
|
Scientific Title of Study
|
A prospective observational study to determine the influence of the UGT1A1 gene polymorphism on the safety profile of IRINOTECAN in cancer patients in a tertiary care centre in South India. |
| Trial Acronym |
IRINOGEN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC No.1910 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Irragam reddy Rahul reddy |
| Designation |
Junior resident |
| Affiliation |
Sri venkateswara institute of medical sciences and research- SPMCW |
| Address |
Plot no: 44, Vinayakapuram colony, padipeta post and village
Dept of Pharmacology, Third floor, Academic building block, SVIMS-SPMCW, Alipiri Road, Tirupati, Andhra Pradesh. 517507.
Chittoor
ANDHRA PRADESH
517503
India |
| Phone |
8332062222 |
| Fax |
|
| Email |
rahulreddy.prabhas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Umamaheswara Rao |
| Designation |
Head of the Department |
| Affiliation |
Sri venkateswara institute of medical sciences and research- SPMCW |
| Address |
Dr. K. Umamaheswara Rao, professor and HoD, flat no. 301, Vedhadri block, SVIMS quarters, SVIMS, Tirupati, 517507.
Dept of Pharmacology, Third floor, Academic building block, SVIMS-SPMCW, Alipiri Road, Tirupati, Andhra Pradesh. 517507.
Chittoor
ANDHRA PRADESH
517503
India |
| Phone |
9849832292 |
| Fax |
|
| Email |
kavetimahesh40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Irragam reddy Rahul reddy |
| Designation |
Junior resident |
| Affiliation |
Sri venkateswara institute of medical sciences and research- SPMCW |
| Address |
Plot no: 44, Vinayakapuram colony, padipeta post and village
Dept of Pharmacology, Third floor, Academic building block, SVIMS-SPMCW, Alipiri Road, Tirupati, Andhra Pradesh. 517507.
Chittoor
ANDHRA PRADESH
517503
India |
| Phone |
8332062222 |
| Fax |
|
| Email |
rahulreddy.prabhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswara institute of medical sciences and research- SBAVP funds |
|
|
Primary Sponsor
|
| Name |
Dr k Umamaheswara Rao |
| Address |
Head of the Department
Department of Pharmacology,
Third floor,
Academic building block,
SVIMS-SPMCW,
Alipiri road,
Tirupati, Andhra Pradesh.
517507 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Irragam reddy Rahul reddy |
Sri venkateswara institute of medical sciences |
Department of Medical Oncology,
SVIMS, Alipiri Road, Tirupati, Andhra Pradesh. 517507.
Chittoor
ANDHRA PRADESH |
8332062222
rahulreddy.prabhas@gmail.com |
| Dr Irragam reddy Rahul reddy |
sri venkateswara institute of medical sciences |
Dept of Biotechnology, SVIMS, Alipiri road, Tirupati, Andhra Pradesh. 517507
Chittoor
ANDHRA PRADESH |
8332062222
rahulreddy.prabhas@gmail.com |
| Dr Irragam reddy Rahul reddy |
Sri venkateswara institute of medical sciences- SPMCW |
The Department of Pharmacology is located on the third floor of the Academic building block at SPMCW, Alipiri Road, Tirupati. 517507
Chittoor
ANDHRA PRADESH |
8332062222
rahulreddy.prabhas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-SVIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, (4) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients (greater than 18 years) with histologically or cytologically confirmed colorectal cancer, pancreatic cancer, or small cell lung cancer who are scheduled to receive or currently receiving an irinotecan-based chemotherapy regimen (e.g., FOLFIRI, FOLFOXIRI, FOLFIRINOX).
2) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.
3) Patients with adequate baseline organ function as per institutional protocol as defined by
Absolute neutrophil count (ANC) greater than or equal to 150 per cu. mm
Platelet count greater than or equal to 100,000 per cu. mm
White blood cell count greater than or equal to 3000 per cu. mm
Serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN) and transaminases less than or equal to 2.5 times ULN (less than or equal to 5 times ULN if liver metastases are present)
Creatinine clearance greater than or equal to 50 mL per min (calculated by Cockcroft–Gault or institutional method)
4) Patients willing and able to provide written informed consent for participation and genetic testing (UGT1A1 genotyping).
5) Patients residing in South India and able to understand study-related instructions in the local language to ensure compliance with follow-up.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant or lactating women.
2) Patients unwilling or unable to provide written informed consent.
3) Patients with inadequate baseline hematological, hepatic, or renal function as defined in the inclusion criteria.
4) Patients with uncontrolled comorbidities (e.g., unstable cardiac disease, uncontrolled hypertension, uncontrolled diabetes) or active infections that may interfere with study participation or irinotecan administration, in the investigator’s judgment.
5) Prior severe hypersensitivity reaction to irinotecan or other components of the planned chemotherapy regimen.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between UGT1A1 gene polymorphisms and the safety profile of irinotecan in patients with colorectal, pancreatic, and small cell lung cancers receiving irinotecan-based regimens at SVIMS, South India. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To determine the frequency distribution of UGT1A1 gene polymorphisms in the study population.
2) To assess the correlation between UGT1A1 polymorphisms and the incidence, severity, frequency, and type of irinotecan-related adverse drug reactions (ADRs).
3) To explore the impact of UGT1A1 polymorphisms on treatment modifications (dose reduction, delay, or discontinuation).
4) To evaluate the role of pharmacogenomic profiling in optimizing irinotecan therapy and improving patient safety.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/04/2026 |
| 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="1"
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 - 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
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 - Proposals should be directed to [rahulreddy.prabhas@gmail.com].
- For how long will this data be available start date provided 01-05-2028 and end date provided 01-05-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This prospective observational study aims to evaluate the influence of UGT1A1 gene polymorphism on the safety profile of irinotecan in cancer patients receiving treatment at a tertiary care centre in South India. Irinotecan is commonly associated with dose-limiting toxicities such as neutropenia and diarrhea, and genetic variations in the UGT1A1 gene are known to affect its metabolism. Eligible cancer patients scheduled to receive irinotecan as part of standard chemotherapy will be enrolled following the acquisition of informed consent. Peripheral blood samples will be collected for UGT1A1 genotyping. Patients will be prospectively monitored for the development and severity of adverse drug reactions, particularly hematological and gastrointestinal toxicities. Adverse events will be graded using standard toxicity criteria. The primary objective is to assess the association between UGT1A1 polymorphism and incidence of severe irinotecan-related toxicities. The findings may help identify patients at increased risk of adverse effects and contribute to safer, individualized chemotherapy in routine clinical practice. |