| CTRI Number |
CTRI/2025/10/096165 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Validation study |
| Study Design |
Other |
|
Public Title of Study
|
Early detection of cancer through CancerSpot test |
|
Scientific Title of Study
|
Blinded Assessment of CancerSpot’s Screening Accuracy in Clinical Cohorts |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS –CS –01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Private Limited |
| Address |
# Room 1, Strand Life Science Private Limited
7th floor, 144, Outer Ring Road,
M S Ramaiah North City, Nagavara
Bangalore
KARNATAKA
560045
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Private Limited |
| Address |
# Room 1, Strand Life Science Private Limited
7th floor, 144, Outer Ring Road,
M S Ramaiah North City, Nagavara
KARNATAKA
560045
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vamsi Veeramachaneni |
| Designation |
Chief Scientific Officer |
| Affiliation |
Strand Life Sciences Private Limited |
| Address |
# Room 1, Strand Life Science Private Limited
7th floor, 144, Outer Ring Road,
M S Ramaiah North City, Nagavara
KARNATAKA
560045
India |
| Phone |
08023095200 |
| Fax |
|
| Email |
vamsi@strandls.com |
|
|
Source of Monetary or Material Support
|
| Strand Life Science Private Limited,
7th floor, 144, Outer Ring Road,
M S Ramaiah North City, Nagavara
Bengaluru, Karnataka-560045 |
|
|
Primary Sponsor
|
| Name |
Strand Life Science Private Limited |
| Address |
Strand Life Science Private Limited,
7th floor, 144, Outer Ring Road,
M S Ramaiah North City, Nagavara
Bengaluru, Karnataka-560045 |
| Type of Sponsor |
Other [Private limited company involved in R and D activities in the field of human biology] |
|
|
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 Tanmoy Kumar Mandal |
Binayak Multispeciality Hospital |
Room 1, Binayak Enclave, 59, Kalicharan Ghosh Road
Kolkata-700050
Kolkata
WEST BENGAL |
9073361042
tanmoy.nrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Binayak Multispecilaity Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with no known symptoms of cancer and no benign or
precancerous lesions |
| Patients |
(1) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, (2) ICD-10 Condition: C18||Malignant neoplasm of colon, (3) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (4) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (5) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (6) ICD-10 Condition: C56||Malignant neoplasm of ovary, (7) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (8) ICD-10 Condition: C16||Malignant neoplasm of stomach, (9) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (10) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cohort 1
1. Patients with pathologically confirmed malignancy of breast, cervix, colorectal,
esophagus, lung, stomach, liver, gallbladder, pancreas and ovary, as identified by the site
Principal Investigator or Co-Investigators.
2. Patients diagnosed with clinical staging I, II and III only
3. Patients who are treatment-naïve (no prior chemotherapy or oncosurgery or oncotherapy
or any oncology investigational agent(s))
4. Willingness to be recontacted by the PI for gathering future clinical status
5. Willingness to provide informed consent
Cohort 2
1. Healthy volunteers with no known symptoms suggestive of cancer including benign,
precancerous lesions as identified by the site Principal Investigator or Co-Investigators
through routine clinical care processes.
2. Willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Cohorts 1 and 2
1. Subjects below 18 years
2. Subjects who have an active or chronic infection
3. Women who are pregnant or suspect they are pregnant and lactating mothers
4. Cases with prior diagnostic complications or unconventional pathology or
rare/unclassified tumor subtypes
5. Subjects with prior history of malignancy (other than the current primary for Cohort 1)
6. Subjects with benign, borderline, or precancerous conditions
7. Subjects with significant comorbidities that, in the opinion of the investigator, may
confound study results (e.g., autoimmune disorders, recent major surgery, organ failure,
etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Validation of CancerSpotTM will aid in early detection of cancer, and aid in future population
screening for early detection of cancer. |
Preliminary assessment at 10 percent of recruitment
Final assessment at the end of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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)
|
28/10/2025 |
| 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="2"
Months="0"
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
|
CancerSpotTM is a non-invasive, blood-based test designed for the early-stage screening of different types of cancer with the ability to predict the top two possible cancer types for 10 different cancers - breast, cervix, colorectal, esophagus, lung, stomach, liver, gallbladder, pancreas, and ovary in treatment-naïve individuals. This test allows the detection of multiple cancer types simultaneously, enhancing the early identification of cancer and improving patient outcomes through earlier intervention. This study is validating CancerSpotTM, a launched blood test designed to detect early-stage cancers by analyzing cancer-specific changes in DNA found in the blood. It is a blinded study, and once the blinding is broken, the results will be used to assess how accurately CancerSpotTM detects cancer (sensitivity) and correctly identifies those without cancer (specificity). Validation of CancerSpotTM will aid in early detection of cancer, and aid in future population screening for early detection of cancer, specially through health check programs. |