Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT02577627
Eligibility Criteria:
Inclusion Criteria:
Lung Cancer (NSCLC):
1. Gender: Female, Male.
2. Age: Eighteen years and older at the start of treatment.
3. Stage: Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, adenocarcinoma, OR Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, NOS.
4. Lung cancer with measurable disease at the start of treatment.
5. No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month before.
6. Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) before treatment.
7. Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) during or after the treatment.
8. Patient has at least one recorded visit to the treating oncologist before treatment.
9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
10. Treatment as per SOC for NSCLC.
Lung Cancer (SCLC):
1. Genders Eligible for Study: Female/Male patient.
2. Ages between 18 and older at the start of treatment.
3. Pathologically or cytologically determined advanced or locally advanced SCLC at Stage III/IV.
4. Lung cancer with measurable disease at the start of treatment.
5. No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago.
6. Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) before treatment.
7. Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after the treatment.
8. Patient has at least one recorded visit to the treating oncologist before treatment.
9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
10. Treatment as per SOC for SCLC.
Colon Cancer:
1. Genders Eligible for Study: Female/Male patient.
2. Ages between 18 and older at the start of treatment.
3. Pathologically or cytologically determined advanced or locally advanced Colon Cancer at Stage III/IV
4. Colon cancer with measurable disease at the start of treatment
5. No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago,
6. Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) before treatment
7. Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after the treatment.
8. Patient has at least one recorded visit to the treating oncologist before treatment
9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
10. Treatment as per SOC for Colon cancer
Breast Cancer:
1. Genders Eligible for Study: Female patient.
2. Ages between 18 and older at the start of treatment.
3. Patients must have histologically confirmed breast malignancy that is either:
* Stage III breast cancer, including inflammatory breast cancer, or
* Stage IV breast cancer in a complete remission (bone only not allowed unless the bone scan is normal).
4. Breast cancer with measurable disease at the start of treatment.
5. No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago.
6. Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) before treatment.
7. Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after treatment.
8. Patient has at least one recorded visit to the treating oncologist before treatment.
9. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
10. Treatment as per SOC for Breast cancer.
Prostate Cancer:
1. Genders Eligible for Study: Male patient.
2. Ages between 18 and older at the start of treatment.
3. Histologically confirmed prostate cancer with progressive metastatic disease based on any of the following:
1. Rise in PSA - a minimum of 3 consecutive rising levels, with an interval of ≥1 week between each determination. The last determination must have a minimal value of ≥ 2 ng/mL and be determined within two weeks prior to enrolment.
2. Measurable Disease by transaxial imaging - patients showing new or progressive soft tissue masses on CT or MRI scans as defined by the PCWG2.
3. Radionuclide bone scan - at least two new metastatic lesions by CT, MRI or by any SOC.
4. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration).
5. Patients must have castrate levels of testosterone (\<50 ng/dl \[1.74 nmol/l\]).
6. Patient has at least one recorded visit to the treating oncologist before treatment.
7. Patient has at least one recorded visit to the treating oncologist during or after the treatment.
8. Treatment as per SOC for Prostate cancer.
Exclusion Criteria:
Lung Cancer (NSCLC):
1\. History of another malignancy within the previous 2 years except for the following:
1. Adequately treated basal cell or squamous cell skin cancer,
2. Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
Lung Cancer (SCLC):
1. History of another malignancy within the previous 2 years except for the following: Adequately treated basal cell or squamous cell skin cancer,
2. Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
Colon Cancer:
1\. History of another malignancy within the previous 2 years except for the following:
1. Adequately treated basal cell or squamous cell skin cancer,
2. Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
Breast Cancer:
1. Patients who have had chemotherapy or radiotherapy within 6 weeks prior to entering the study.
2. History of another malignancy within the previous 2 years except for the following:
1. Adequately treated basal cell or squamous cell skin cancer,
2. Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
Prostate Cancer:
1. History of, or current known metastases in the brain or untreated spinal cord compression;
2. History of another malignancy within the previous 2 years except for the following:
1. Adequately treated basal cell or squamous cell skin cancer,
2. Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
3. Patients have received prior cytotoxic chemotherapy for Prostate cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT02577627
Study Brief:
Protocol Section:
NCT02577627