iquid biopsy for early detection of cancer
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2019/01/017219
- Lead Sponsor
- Datar Cancer Genetics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Non-cancer arm-
For Inclusion, an individual must meet all of the following criteria:
1.Age â?? 49 to 75 years for males and 40 to 75 years for females
2.Participants with no known diagnosis or past history of cancer
3.Willingness to provide blood sample as per study protocol
4.Patient should be willing for screening investigations proposed in study protocol.
5.Female patient is not pregnant / lactating (self-report)
6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
7.Stated willingness to comply with all study procedures
Cancer arm-
For Inclusion, an individual must meet all of the following criteria:
1.Age â?? 49 to 75 years for males and 40 to 75 years for females
2.Able to provide a written informed consent
3.Have either of the following:
a.Confirmed cancer diagnosis (any stage I-IV) within 90 days prior to study blood draw, based upon assessment of a pathological specimen and are therapy naïve at the time of blood collection
OR
b.A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw and are therapy naïve at the time of blood collection
4.Willingness to provide blood sample as per study protocol
5.Female patient is not pregnant / lactating (self-report)
6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
7.Stated willingness to comply with all study procedures
Benign lesions arm-
For Inclusion, an individual must meet all of the following criteria:
1.Age â?? 49 to 75 years for males and 40 to 75 years for females
2.Able to provide a written informed consent
3.Have either of the following:
a.Confirmed diagnosis of a benign lump within 90 days prior to study blood draw, based upon assessment of a pathological specimen and are therapy naïve at the time of blood collection
OR
b.A high suspicion for a benign lump by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw and are therapy naïve at the time of blood collection
4.Willingness to provide blood sample as per study protocol
5.Female patient is not pregnant / lactating (self-report)
6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
7.Stated willingness to comply with all study procedures
Non-cancer arm-
For Exclusion, an individual may meet any of the following criteria:
1.Known current or prior diagnosis of cancer
2.Unable to provide informed consent
3.Unable to comply with all project screening procedures
4.Current treatment with any investigational drug or intervention
5.Pregnant or lactating women (by self-report)
6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
7.Unable/unwilling to provide blood sample as per study requirement.
8.Oral or IV corticosteroid use in past 14 days prior to blood draw
9.Current febrile illness
10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
Cancer arm-
For Exclusion, an individual may meet any of the following criteria:
1.Known prior history of cancer or history of prior or current cancer treatment
2.Unable to provide informed consent
3.Unable to comply with all project screening procedures
4.Current treatment with any investigational drug or intervention
5.Pregnant or lactating women (by self-report)
6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
7.Unable/unwilling to provide blood sample as per study requirement.
8.Oral or IV corticosteroid use in past 14 days prior to blood draw
9.Current febrile illness
10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
Benign lesions arm-
For Exclusion, an individual may meet any of the following criteria:
1.Known prior history of cancer or history of prior or current cancer treatment or a high suspicion for a cancer diagnosis
2.Unable to provide informed consent
3.Unable to comply with all project screening procedures
4.Current treatment with any investigational drug or intervention
5.Pregnant or lactating women (by self-report)
6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
7.Unable/unwilling to provide blood sample as per study requirement.
8.Oral or IV corticosteroid use in past 14 days prior to blood draw
9.Current febrile illness
10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SpecificityTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method SensitivityTimepoint: 12 months