Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
None listed
Sponsors
Datar Cancer Genetics Limited
Canconnect Foundation
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the performance characteristics of TruBlood in detecting cancers and establishing cancer diagnosis, and discerning cancers from benign cases and asymptomatic individuals. Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final) | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the clinical utility of TrueBlood test for functional evaluation of malignancy, Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To determine the clinical utility of TrueBlood test for longitudinal monitoring of malignancies.Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To determine the clinical utility of TrueBlood test for molecular evaluation of malignancy,Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To determine the clinical utility of TrueBlood test for response or resistance profiling of malignancy towards anticancer agents,Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To determine the clinical utility of TrueBlood test for theranostic or therapeutically- relevant typing of malignancy, Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To determine the clinical utility of TrueBlood test for morphological / histopathological typing of malignancy.Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final);To identify and determine the clinical utility and performance characteristics of other additional circulating tumor and tumor cell biomarkers for screening, detection, diagnostic, localization, theranostic or prognostic application in malignancies.Timepoint: Evaluation Timepoints: Day 0 (baseline: sample collection) Day 180 (interim) Day 360 (final) | — |
Countries
India
Contacts
Public ContactDr Dadasaheb Akolkar
Datar Cancer Genetics Limited
Outcome results
None listed