| 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
|
|
|
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
|
|
|
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
|
|
|
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 nonÂinvasive, 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. |