Study of blood and sputum samples of healthy humans and patients for cancer research.
- Conditions
- Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
- Registration Number
- CTRI/2023/01/048765
- Lead Sponsor
- Oxford Cancer Analytics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Cohort I:
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
row).
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).
Cohort II and Cohort III:
1. Patients diagnosed with Stage I/II/III/IV lung cancer, most likely NSCLC
a. Stage I/II lung cancer (Cohort II Only)
b. Stage III/IV lung cancer (Cohort III Only)
2. Male and/or female patients aged 50-80 years.10
3. Patients with smoking history of at least 20 pack-years.
4. If former smoker, the patient has quit smoking within the past 15 years.
5. Patients who have not gone through treatment (surgery, drugs, radiation).
6. Patients or Legally Acceptable Representative (for the patients with low literacy) who
provides informed consent.
Cohort I:
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.
10. Matched plasma and sputum samples from the same subject is required for the study.
Priority will be given to the plasma (blood) if sputum is unavailable.
11. Female subjects found to be positive during pregnancy test done prior to commencement of study.
12. Lactating females.
13. Any other medical condition, as per the discretion of the investigator, precludes the subject’s participation in the study.
Cohort II and Cohort III:
1. Patient with the habit of tobacco chewing.
2. Patient with previous diagnosis of lung cancer except stage IV in case of metastasis (spread of cancer to other parts of body). The patient can be included in the stage IV (Cohort III) in case of metastasis.
3. Patient with previous history/treatment of any kind of cancer.
4. Patients who have completed treatments for any kind of cancer (surgery, drugs, radiation).
5. Patients with recent myocardial infarction (MI) history (within 6 months).
6. Patients unwilling to be part of the study.
7. Patients having history or presence for disease markers of HIV 1 and 2, Hepatitis B and C and RPR test for Syphilis.
8. Patients having difficulty in accessibility of veins for blood sampling and or difficulty donating blood
9. Patients having hypersensitivity toward Albuterol.
10. Matched plasma and sputum samples from the same patient are required for the study. Priority will be given to the plasma (blood) if sputum is unavailable.
11. Female patients found to be positive during pregnancy test done prior to commencement of study.
12. Lactating females.
13. Any other medical condition, as per the discretion of the investigator, precludes the patient’s participation in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.Timepoint: there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.
- Secondary Outcome Measures
Name Time Method there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.Timepoint: there is no primary outcome in this sample collection only observational study. Also there is no intervention involved in the study, Hence objective/endpoint to determine its effect is not applicable.