iquid Biopsy for Cancer Screening

Not Applicable

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

• Registration Number: CTRI/2021/11/038185
• Lead Sponsor: Datar Cancer Genetics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

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 nalve 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

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,

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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