FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/038185 [Registered on: 22/11/2021] Trial Registered Prospectively
Last Modified On: 23/11/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Liquid Biopsy for Cancer Screening 
Scientific Title of Study   Clinical Utility of a Circulating Tumor Cell Detection Test for Detection of Soild Organ Cancers in Asymptomatic Individuals  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashant Lad 
Designation  Surgical Oncologist 
Affiliation  Om Sai Onco Surgery Centre 
Address  R. S. No. 457/10, Dr. LAD Colony, Out Patient Department, Block-A, Sugar Mill Corner, Main Road, Kasaba Bawada, Kolhapur, Maharashtra 416006

Kolhapur
MAHARASHTRA
416006
India 
Phone  8237772626  
Fax    
Email  omsaicr17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dadasaheb Akolkar  
Designation  Director- Research and Innovations  
Affiliation  Datar Cancer Genetics Private Limited  
Address  Department - Research and Innovations Dartar Cancer Genetics F-8, D Road, Ambad, MIDC

Nashik
MAHARASHTRA
422010
India 
Phone  02536690804   
Fax    
Email  dadasaheb.akolkar@datarpgx.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudha Murthy  
Designation  Director – Clinical Support  
Affiliation  Datar Cancer Genetics Private Limited  
Address  Department - Research and Innovations Dartar Cancer Genetics F-8, D Road, Ambad, MIDC

Nashik
MAHARASHTRA
422010
India 
Phone  9607007939   
Fax    
Email  sudha.murthy@datarpgx.org  
 
Source of Monetary or Material Support  
Datar Cancer Genetics Private Limited, F-8, D Road, Ambad, Nashik, Maharashtra, India, 422010 
 
Primary Sponsor  
Name  Datar Cancer Genetics Private Limited  
Address  Datar Cancer Genetics Private Limited, F-8, D Road, Ambad, Nashik, Maharashtra, India, 422010 
Type of Sponsor  Other [Private Molecular Laboratory] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kakali Chodhury  Health Point Hospital  Department of Oncology, Room no. 12, 21, Prannath Pandit St, Lansdown, Paddapukur, Bhowanipore, Kolkata, West Bengal 700025
Kolkata
WEST BENGAL 
9002976897

mailkakalichoudhury@gmail.com 
Dr Suparna Kanti Pal  Indopath Clinical Private Limited   Out Patient Department, Room no. 1, Rabindra sadan gate no 4, 87, Chowringee Rd, Gokhel Road, Bhowanipore, Kolkata, West Bengal 700020
Kolkata
WEST BENGAL 
8910542017

suparna.k.pal@gmail.com 
Dr Prashant Lad  Om Sai Onco Surgery Centre  R. S. No. 457/10, Dr. LAD Colony, Out Patient Department, Block-A, Sugar Mill Corner, Main Road, Kasaba Bawada, Kolhapur, Maharashtra 416006
Kolhapur
MAHARASHTRA 
8237772626

omsaicr17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Health Point Ethics Committee  Approved 
Health Point Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with no known diagnosis or past history of cancer. 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult males and females, aged 30 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. Female participants: neither pregnant, nor lactating

6. For Cohort A (Suspected Cases)

a. No prior diagnosis .of (any) cancer,

b. Presenting with symptoms or radiological I clinical findings suspected of solid

organ cancer (priority for localized cancer),

c. Biopsy na"lve and posted to undergo tissue biopsy for histopathological examination (HPE) as part of standard diagnostic procedure,

d. Willing to share HPE findings for the study,

e. Optional: Willing for 1-year telephonic follow-up if diagnosed with non­ malignant conditions.

7. For Cohort B (Asymptomatic Individuals)

a. Baseline risk of cancer,

b. Non-smoker ,

c. No elevated risk of cancer associated with lifestyle, occupation or any other socioeconomic factors,

d. No diagnosis (or sympto ms suggestive) of chronic or new onset diabetes,

chronic pulmonary disease or chronic gastrointestinal disease,

e. Normal CBC, blood glucose, liver function test and kidney function test,

f. No family history of cancer,

g. No known genetic predisposition for cancer,

h. No prior diagnosis of (any) cancer,

i. No prior diagnosis of benign or chronic inflammatory conditions ,

j. . No current symptoms or radiological I clinical findings suspected of cancer or

benign conditions.

k. Optional: Willing for 1-year telephonic follow-up.
 
 
ExclusionCriteria 
Details  1. Failure to meet general cohort-specific Inclusion Criteria,

2. Age less than 30 years ,




3. Inability to provide Informed Consent,

4. Co-morbidities which could impair study participation or sample collection,

5. Current febrile illness,

6. Chronic or acute inflammatory conditions within past 14 days,

7. Positive for HIV/HBV/HCV,
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Specificity and Sensitivity of the Test for detection and tissue/organ of origin localization of cancers and differentiating cancer cases from benign cases and asymptomatic individuals  12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Specificity and Sensitivity of the Test for molecular , theranostic and drug response­ resistance profiling as well as longitudinal monitoring of cancer .  12 months  
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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)   23/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/11/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

According to the most recent predictions by the International Agency for Research on Cancer GLOBOCAN project, India’s cancer burden will nearly double in the next 20 years, from a million new cases in 2012 to more than 1.7 million by 2035. The age-standardized prevalence of cancer is estimated to be 97 per 100,000 persons with greater prevalence in urban areas. The evidence suggests that cancer prevalence is highest among the elderly and also among females in the reproductive age groups. In general, there is a consensus that about 60 percent of cancer deaths can be prevented with improved preventive (removing the causes of disease so theta exposure to risk is minimal) and screening (test or procedure used to detect disease) facilities. A key factor responsible for high cancer mortality (at 68% of the annual incidence) and lower survival in cancer patients is the late stage of diagnosis. Hence early detection is the key to improve disease outcomes with increased disease free and overall survival. Currently there are no high sensitivity and specificity screening tools available which can detect all cancers at early stage with minimal harm to the patient and can be used as a mass screening tool even for the patients without access to advanced healthcare facilities. Liquid biopsy involves the analysis of biomarkers like circulating tumor cells (CTCs), cell-free nucleic acids -circulating free DNA (cfDNA), exosomal messenger RNA (mRNA) and micro RNA (miRNA) in bodily fluids such as blood. However, development of methods for noninvasive detection of cancer has still not been standardized. Circulating tumor cells (CTCs) are the tumor cells which have detached from primary tumor site and have gained access to peripheral circulation. These may potentially lodge in distant organs giving rise to metastasis. Thus, CTCs are a pre-requisite for distant disease spread and are detectable before late stage/metastatic disease develops. CTCs have additional advantage of expressing tissue-of-origin specific markers giving rise to possibility of identification of primary tumor site. The evaluation of CTCs in cancer management, has potential to extend beyond prognostication. As technologies emerge to analyze CTCs at the molecular level, biological behavior of the tumor can be obtained in real time, with the promise of CTCs eventually acting as a ‘surrogate tumor biopsy’. All in all, CTC-based liquid biopsy has potential for non­invasive, accurate blood based cancer screening modality to improve patient care and quality of life. Current study is undertaken to evaluate the feasibility of a CTC based test for cancer screening in asymptomatic individuals. This is an observational study to evaluate the clinical utility and performance of a CTC based test for detection of solid organ cancers. The study has 2 cohorts, viz., suspected cases of cancers and asymptomatic individuals with no prior diagnosis of cancer or symptoms suspected of cancer. A cumulative enrollment of 10000 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. The suspected cases will subsequently undergo a tumor tissue biopsy as part of standard diagnostic work up (outside the scope of the study), and the findings will be made available to the study investigators. Consenting participants in the asymptomatic cohort as well as those in the symptomatic cohort diagnosed with benign conditions will be telephonically followed up for 1 year for any diagnosis of cancer or symptoms suspected of cancer necessitating a diagnostic work-up. On the completion of the cohorts, data will be analyzed to evaluate the study objectives. The primary objective is to determine the performance characteristics of a Circulating Tumor Cell based Test for detection and tissue/organ of origin localization of cancers and differentiating cancer cases from benign cases and asymptomatic individuals. The secondary objective is to determine the clinical utility of a Circulating Tumor Cell based Test for molecular, theranostic and drug response-resistance profiling as well as longitudinal monitoring of cancer. The exploratory objectives is to identify and determine the performance characteristics of other additional biomarkers in cancers. The primary outcome measure is to determine Specificity and Sensitivity of the Test for detection and tissue/organ of origin localization of cancers and differentiating cancer cases from benign cases and asymptomatic individuals. The secondary outcome measure is to determine Specificity and Sensitivity of the Test for molecular, theranostic and drug response­ resistance profiling as well as longitudinal monitoring of cancer.

 
Close