Department of Surgical Oncology,
804/2, 805/2, E Ward, Circuit House To Kadamwadi Road, Bhosalewadi, Kolhapur, 416003 Kolhapur MAHARASHTRA
8655635668
dryashashvi@gmail.com
Dr Rohan Kharde
Dr. Vithalrao Vikhe Patil Foundation Medical College and Hospital
Department of Radiotherapy and Oncology, MIDC Vadgaon Gupta, Vilad Ghat
Ahmednagar, 414 111 Ahmadnagar MAHARASHTRA
9975703033
drrohankharde@gmail.com
Dr Kumar Saurabh
Health Point Hospital
Department of Medical Oncology, Health Point Hospital, next to RIMS, near Medical Chowk, Bariatu, Ranchi, Jharkhand, 834009 Ranchi JHARKHAND
7761848530
ksoncologist@gmail.com
Dr Bidisha Ghosh Naskar
Health Point Hospital, Kolkata
Department of Radiation Oncology, 21, Prannath Pandit St, Lansdown, Paddapukur, Bhowanipore, Kolkata, West Bengal, 700025 Kolkata WEST BENGAL
9432164842
bghoshn@gmail.com
Dr Piyush Kedia
Horizon Life Line Pvt Ltd, Kolkata
P- 34, NANIGOPAL ROY CHOWDHURY AVENUE,
Near Moulali Philips Bus Stop, CIT Rd, Sealdah, Kolkata, West Bengal 700014 Kolkata WEST BENGAL
9831060265
dr_piyushkedia@hotmail.com
Dr Suparna Kanti Pal
Indopath Clinical Private Limited
Department of Radiation Oncology, Rabindra sadan gate no 4, 87, Chowringee Rd, Gokhel Road, Bhowanipore, Kolkata, West
Bengal 700020 Kolkata WEST BENGAL
7980253154
suparna.k.pal@gmail.com
Dr Digvijay Balasaheb Patil
Krishna Institute of Medical Sciences, Deemed to be University
Department of Surgical Oncology, Malkapur, Karad, 415539
Satara MAHARASHTRA
9712648402
drdigvijayp@gmail.com
Dr Prashant P Lad
Om Sai Onco Surgery Centre
Department of Surgical Oncology, R. S. No. 457/10, Dr. LAD Colony, Block-A, Sugar Mill Corner, Main Road, Kasaba Bawada, Kolhapur, 416006 Kolhapur MAHARASHTRA
Institutional Ethics Committee, Krishna Institute of Medical Sciences, Deemed to be University, Karad
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Royal Pune Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C00-D49||Neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Adult males and females, aged 18 years and above,
2. Provision of Informed Consent,
3. Willing and able to participate in the study and provide blood sample.
4. No co-morbidities which could impair study participation or procedures,
5. No prior diagnosis of any cancer,
6. Suspected of primary malignancy of either the brain, breast, lung, prostate, pancreas, bile duct or gallbladder, and posted to undergo an invasive biopsy as part of standard diagnostic procedures.
ExclusionCriteria
Details
1. Failure to meet Inclusion Criteria,
2. Age less than 18 years,
3. Inability to provide Informed Consent,
4. Co-morbidities which could impair study participation or sample collection,
5. Positive for HIV / HBV / HCV,
6. Prior diagnosis of any malignancy,
7. Unable to undergo an invasive biopsy as part of standard diagnostic procedures.
8. Suspicion of hematological, lymphoid or myeloid malignancies.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Sensitivity of the Test for detection and localization of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer.
1 year
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="850" Sample Size from India="850" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Diagnosis of most types of cancers in symptomatic individuals is based on Histopathological Evaluation (HPE) of tumor tissue or other biological specimen (e.g., bone marrow aspirate) obtained by an invasive biopsy. Such biopsies are specialized invasive procedures with significant morbidity and financial implications. In addition, they necessitate patient’s visits to a tertiary care center with specialized facilities. Apart from the logistical aspects, there are other factors which impact tumor tissue procurement such as inaccessibility of the tumor, proximity of the tumor to vital organs or vasculature, patients’ comorbidities or even patients’ reluctance due to procedural risks. Repeat biopsies may oftentimes be desirable such as (a) where the prior tissue sample was insufficient or poorly representative or (b) for determining status of therapeutically relevant biomarkers or (c) for characterization of recurrent lesions or (d) for identification of a new lesion as a second primary or metastasis. However, repeat biopsies are associated with increased procedural risks.
This is a blinded, prospective, observational study to evaluate the clinical utility and performance of a CTC based test for detection and localization of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. The study objective is to determine the performance characteristics of the test for detection and localization of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. The study population includes adult males and females presenting with symptoms or clinical / radiological findings, suspected of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. For enrollment, priority will be given to individuals suspected of early-stage disease (localized to primary organ, no lymph node involvement) in case of breast, lung, prostate, pancreas, bile duct or gallbladder cancers. A cumulative enrollment of 850 individuals is planned. The study investigator or an authorized representative will identify individuals eligible for the study, based on the inclusion/exclusion criteria. After providing all necessary information related to study, and after obtaining written informed consent from eligible participants, 15 ml blood will be drawn from all participants as per study protocol. On the completion of the cohorts, data will be analyzed to evaluate the study objectives.