iquid biopsy to replace tissue biopsy

Not Applicable

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2019/03/017918
• Lead Sponsor: Datar Cancer Genetics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For Inclusion, an individual must meet all of the following criteria. Inability to meet all inclusion criteria for a cohort will lead to exclusion.

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, as well as other (e.g., tissue, CSF, AF, PF, BM) samples as per availability and feasibility.

4. No co-morbidities which could impair study participation or sample collection,

5. Female participants: neither pregnant, nor lactating

6. For Cohort A (Known Cancer Cases)

(6a). Diagnosed with any malignancy as per current appropriate Standard of Care approach (e.g., HPE confirmed diagnosis of solid organ cancer)

(6b). Therapy Naïve as well as Received prior anticancer treatments.

7. For Cohort B (Suspected Cases)

(7a). No prior diagnosis of (any) cancer,

(7b). Presenting with radiological or clinical symptoms suspected of localized solid organ cancer and posted to undergo tissue biopsy as part of standard diagnostic procedure.

8. For Cohort C (Known Benign Cases)

(8a). No prior diagnosis of any cancer

(8b). Confirmed diagnosis of benign (non-cancerous / non-malignant) conditions as per relevant Standard of Care diagnostic work-up.

Exclusion Criteria

For Exclusion, an individual may meet any of the following criteria. Meeting even one exclusion criteria will lead to exclusion.

1. Age less than 18 years,

2. Inability to provide Informed Consent,

3. Co-morbidities or ongoing treatments which could impair study participation or sample collection

4. Current febrile illness

5. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to screening,

6. Blood transfusion within 14 days prior to screening,

7. CT / PET-CT within 14 days prior to screening,

8. Positive for HIV / HBV / HCV,

9. Failure to meet general or cohort-specific Inclusion Criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the performance characteristics of TruBlood in detecting cancers and establishing cancer diagnosis, and discerning cancers from benign cases and asymptomatic individuals. <br/ ><br>Timepoint: Evaluation Timepoints: <br/ ><br>Day 0 (baseline: sample collection) <br/ ><br>Day 180 (interim) <br/ ><br>Day 360 (final)