Skip to content

Liquid Biopsy for Cancer Screening

Clinical Utility of a Circulating Tumor Cell Detection Test for Detection of Soild Organ Cancers in Asymptomatic Individuals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/11/038185
Enrollment
10000
Registered
2021-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

None listed

Sponsors

Datar Cancer Genetics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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,

Design outcomes

Primary

MeasureTime frame
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 individualsTimepoint: 12 months

Secondary

MeasureTime frame
Specificity and Sensitivity of the Test for molecular , theranostic and drug response�­ resistance profiling as well as longitudinal monitoring of cancer .Timepoint: 12 months

Countries

India

Contacts

Public ContactDr Sudha Murthy

Datar Cancer Genetics Private Limited

dadasaheb.akolkar@datarpgx.com02536690804

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026