IRB Study Number A212102
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary objective
To provide a blinded reference set of cancer vs. non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.
2.2 Secondary objectives
2.2.1 Evaluate test performance at the time of initial cancer diagnosis by tumor type
2.2.2 Evaluate test performance at the time of initial cancer diagnosis by clinical stage
Inclusion Criteria
3.2 Eligibility Criteria for Participants with a Cancer Diagnosis
Use the spaces provided to confirm a patient’s eligibility by indicating Yes or No as appropriate. It is not required to complete or submit the following page(s).
When calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test were done on a Monday, the Monday one week later would be considered Day 7.
A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
3.2.1 Documentation of Disease:
Histologic Documentation: Histologically confirmed diagnosis of invasive cancer
Stage: Stage I-IV per AJCC 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma.
For leukemia: Type (CLL, CML, ALL, AML)
For lymphoma: Stage I-IV based on Ann Arbor staging
For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
One of the following tumor types:
a) Colorectal
b) Bladder
c) Head and Neck
d) Hepatobiliary
e) Lung
f) Lymphoma
g) Leukemia
h) Ovary*
i) Pancreas*
j) Multiple Myeloma
k) Gastric, esophageal or gastroesophageal
l) Breast
m) Thyroid
n) Kidney*
o) Endometrium
p) Prostate
q) Melanoma*
r) Sarcoma
*For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the Study Chairs to review appropriateness for enrollment. See Section 4.3.2. Eligibility criteria for these patients are listed in Section 3.4.
3.2.2 No prior definitive systemic or local anti-cancer intervention.
3.2.3 Age ≥ 40 and ≤ 75
3.2.4 No known current pregnancy by self-report
3.2.5 No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis.
3.2.6 Willingness to provide blood samples for research use.
3.2.7 Absence of medical contraindications to a research blood draw volume of 60mL
3.2.8 No history of organ transplantation
3.2.9 Ability to read and comprehend English or Spanish
Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages.
3.3 Eligibility Criteria for Participants without a Cancer Diagnosis and without Suspicion of Cancer
3.3.1 Age ≥ 40 and ≤ 75
3.3.2 No known current pregnancy by self-report
3.3.3 No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
3.3.4 Willingness to provide blood samples for research use
3.3.5 Absence of medical contraindications to a research blood draw volume of 60mL
3.3.6 No history of organ transplantation
3.3.7 Ability to read and comprehend English or Spanish
Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages.
3.4 Eligibility Criteria for Participants with a High Suspicion of Cancer
3.4.1 High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw.
Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma.
3.4.2 Central review of radiology reports and/or clinical documentation conducted by Study Chairs (see Section 4.3.2).
3.4.3 Age ≥ 40 and ≤ 75
3.4.4 No known current pregnancy by self-report
3.4.5 No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
3.4.6 Willingness to provide blood samples for research use
3.4.7 Absence of medical contraindications to a research blood draw volume of 60mL
3.4.10 No history of organ transplantation
3.4.11 Ability to read and comprehend English or Spanish
Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages.
Exclusion Criteria
Exclusion Criteria Not Available
