CTRI/2023/01/048765
Recruiting
N/A
Collection of blood and sputum samples from healthy subjects and patients with lung cancer for characterization of cancer biomarkers to develop an early-stage liquid biopsy-based cancer screening test.
Oxford Cancer Analytics0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
- Sponsor
- Oxford Cancer Analytics
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and/or female subjects aged 50\-80 years.
- •2\. Weight not less than 50 kg for male and 45kg for female.
- •3\. Subjects who smoke cigarettes daily for at least 20 years (not necessarily 20 years in a
- •4\. Subjects with smoking history of at least 20 pack\-years (can be discontinuous).
- •(Pack\-year is a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack year is equal to smoking 1 pack per day for 1 year, or 2 packs per day for half a year, and so on)
- •5\. If former smoker, the subject has quit smoking within the past 15 years. 10,11
- •6\. Subjects who have not gone through treatments (surgery, drugs, radiation).
- •7\. Subjects or Legally Acceptable Representative (for the subjects with low literacy) who provides informed consent.
- •8\. Free of significant diseases or clinically significant abnormal findings during screening,
- •medical history, physical examination, 12 Lead Electrocardiogram (12 Lead ECG), chest X\-Ray and laboratory evaluations (haematology, serum chemistry, urine analysis).
Exclusion Criteria
- •1\. Subjects with the habit of tobacco chewing.
- •2\. Subjects with previous diagnosis of lung cancer.
- •3\. Subjects with previous history of any kind of cancer diagnosis.
- •4\. Subjects who have completed treatments related to any kind of cancer (surgery, drugs,
- •radiation).
- •5\. Subjects with recent myocardial infarction (MI) history (within 6 months).
- •6\. Subjects unwilling to be part of the study.
- •7\. Subjects having history or presence for disease markers of Human Immunodeficiency Virus 1 (HIV 1\) and 2, Hepatitis B and C and Rapid Plasma Reagin (RPR) test for Syphilis.
- •8\. Subject having difficulty in accessibility of veins for blood sampling and or difficulty with donating blood.
- •9\. Subjects having hypersensitivity toward Albuterol.
Outcomes
Primary Outcomes
Not specified
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