Detecting cancers Earlier Through Elective plasma-based CancerSEEK Testing - Ascertaining Serial Cancer patients to Enable New Diagnostic II (DETECT-ASCEND 2) - DETECT ASCEND 2

Exact Sciences Thrive LLC0 个研究点目标入组 294 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•All subjects
•1. >=50 years of age
•2. Subject understands the study procedures and is able to provide informed
•consent to participate in the study and authorization for release of relevant
•protected health information to the study investigator.
•Cancer Subjects Only
•3. Subject has an untreated primary malignancy of breast, lung, colorectal,
•prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach,
•ovarian, esophageal cancer, head and neck squamous cell, thyroid, small
•intestine, cervical, anal, vulva, or testis confirmed through pathology reports
•and/or clinical/radiographic data.
•4. Subject has suspicion of a primary malignancy of pancreatic, bladder,
•kidney/renal pelvis, testis or ovarian cancer based on imaging.

•1. Prior or concurrent cancer diagnosis defined as:
•a. Any previous cancer diagnosis within the past 5 years (with the exceptions
•of basal cell or squamous cell skin cancers); OR
•b. Recurrence of the same primary cancer within any timeframe; OR
•c. Concurrent diagnosis of multiple primary cancers
•2. Chemotherapy and/or radiation therapy within 5 years prior to
•enrollment/sample collection.
•3. Any treatment for the primary malignancy or sites of metastases. Subject may
•not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy,
•immunotherapy or other treatment and/or surgery prior to blood sample
•collection.
•4. Less than 3 days between fine needle aspiration (FNA) of target pathology
•and blood collection.
•5. Less than 7 days between biopsy (other than FNA) of target pathology and
•blood collection.
•6. IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] prior to blood
•collection.
•7. Individual has a condition the Investigator believes would interfere with
•the subject*s ability to provide informed consent, comply with the study
•protocol, which might confound the interpretation of the study results or put
•the person at undue risk.
•8. Participant has an active febrile infection prior to blood draw
•9. History of an allogeneic bone marrow, stem cell transplant, or solid organ

发起方

Exact Sciences Thrive LLC