Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test
Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test
This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.
Inclusion Criteria:
Subjects must meet the following criteria in order to be included in the research study:
Inclusion Criteria Arm 1 - Cancer Subjects Arm 1 subjects enrolled in the study must meet the following inclusion criteria.
Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)
Arm 2 subjects enrolled in the study must meet the following inclusion criteria:
Part 1B Only :
- Subject has no known current cancer and has 1 of the follow conditions:
o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm
Exclusion Criteria:
Subject self-reporting OR available medical records at the time of screening are acceptable for assessment of all exclusion criteria.
Exclusion Criteria - Both arms
Subjects who meet any of the following criteria will be excluded from study entry:
Exclusion Criteria Arm 1 - Cancer Subjects
Subjects who meet any of the following criteria will be excluded from study entry:
Subject with a prior history of cancer within 5 years will not be allowed to participate in the study
More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast cancer and newly diagnosed lung cancer would be excluded; subject with prior (>5 years ago) treated breast cancer without recurrence and presenting with newly diagnosed lung cancer would be eligible).
Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer:
The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
Subject who has undergone a bowel preparation for a gastrointestinal malignancy within 3 days of an anticipated blood draw.
Exclusion Criteria Arm 2 - Non-cancer Subjects
Subjects who meet any of the following criteria will be excluded from study entry:
- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
Camillus, New York 13031, United States
East Syracuse, New York 13057, United States
Fayetteville, New York 13066, United States
Allentown, Pennsylvania 18104, United States