| CTRI Number |
CTRI/2024/05/066973 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on examining how biological markers impact treatment outcomes for anal cancer patients undergoing chemo and radiation therapy |
|
Scientific Title of Study
|
An ambispective study on outcomes in anal cancers receiving chemo-radiation with exploratory biomarker analysis
|
| 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 Satyajit Pradhan |
| Designation |
Professor Radiation Oncology and Director, MPMMCC and HBCH Varanasi |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Department of Radiation Oncology
Mahamana Pandit Madanmohan Malaviya Cancer Centre
and Homi Bhabha Cancer Hospital, Sundarpur, Varanasi, Uttar Pradesh, 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9415228261 |
| Fax |
|
| Email |
satyajit.pr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tanay Bhadbhade |
| Designation |
Resident Doctor |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Department of Radiation Oncology
Mahamana Pandit Madanmohan Malaviya Cancer Centre
and Homi Bhabha Cancer Hospital, Sundarpur, Varanasi, Uttar Pradesh, 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9370101099 |
| Fax |
|
| Email |
tanaybhadbhade99@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lincoln Pujari |
| Designation |
Associate Professor |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Department of Radiation Oncology
Mahamana Pandit Madanmohan Malaviya Cancer Centre
and Homi Bhabha Cancer Hospital, Sundarpur, Varanasi, Uttar Pradesh, 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
7735661666 |
| Fax |
|
| Email |
drlincoln.pujari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Intramural Funding , Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundarpur, Varanasi, Uttar Pradesh, 221005 |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Tata Memorial Centre, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SATYAJIT PRADHAN |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Department of Radiation Oncology, Sunder Bagiya Sunderpur Varanasi UTTAR PRADESH Varanasi UTTAR PRADESH |
9415228261
satyajit.pr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MPMMCC AND HBCH VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C211||Malignant neoplasm of anal canal, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Histological diagnosis of Squamous cell carcinoma of anal canal.
-Patients being treated with curative intent with concurrent chemo- radiotherapy (CTRT)
-Age of patient 18 years or older
-ECOG status 0 – 2
-Patient consenting for participation in study (Written informed consent for prospective patients, Telephonic informed consent for retrospective patients)
|
|
| ExclusionCriteria |
| Details |
-Unwilling to participate in the study.
-Presence of distant metastases.
-Medical condition precluding curative intent treatment for the patient.
-History of previous treatment for current condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expression of various molecular markers (p16, p53, PD-L1 and CAIX) in patients with anal cancer and correlate this with response to chemo-radiotherapy and treatment response rates at 6 months. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Baseline expression of these moecular markers and their association with acute treatment toxicities based on RTOG toxicity criteria and disease status at 6 months. Also the prevalence of molecular markers in the study population. and association between presence of these molecular markers, patient and disease characteristics and disease outcomes.
|
1.5 Years |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/05/2024 |
| 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="6" 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
|
The incidence of Anal cancers in India
is increasing and there has been a sharp rise in the incidence in the past
decade. The established treatment for anal canal cancer is concurrent
chemoradiotherapy.
Anal canal cancer is found to be
associated with various biomarkers. The presence of these biomarkers can give
invaluable insight into their association with anal cancer its and prognosis
and outcomes. In the long run, this will benefit the scientific community in
predicting anal cancer outcomes and developing new targeted therapy that may
change the efficacy of treatment.
In this study, we study the anal cancer in
detail and various markers associated with it. We will use already collected tissue
biopsy from patients showing signs and symptoms relevant to anal cancer and
once carcinoma is established, we will use that biopsied sample to check for
molecular markers. The presence of markers will be documented and will be correlated
with response to chemo-radiotherapy and survival and any association between
presence of these molecular markers, patient and disease characteristics and
disease outcomes. Treatment will be according to the standard protocol and no
additional tests will be required. This study will be conducted at Mahamana
Pandit Madan Mohan Malviya Cancer Centre & HBCH, Tata Memorial centre, Varanasi. |