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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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