DETECT-ASCEND 2

Trial Info

Status: Open

Specialty: Multiple (Bladder, Breast, Colorectal, Gynae, Head & Neck, Lung, Prostate, Renal, Upper GI)

Date Opened: 01/11/2022

Planned Close Date: 30/12/2022

Sponsor: Exact Sciences Thrive LLC

Principal Investigator: Dr Pierre Martin-Hirsch

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

Trial Description

This is a prospective, observational study of cancer and healthy subjects.

CancerSEEK is a blood test (also called a liquid biopsy) designed to detect multiple types of cancer at the earliest stages possible. The CancerSEEK test has been shown in both retrospective and prospective settings to be able to detect many different types of cancer for which routine, standard-of-care (SOC) screening modalities are not presently available (Cohen et al., 2018), (Lennon et al., 2020). CancerSEEK, as a minimally invasive multi cancer screening test, employed in a complimentary fashion with currently approved SOC cancer screening approaches may be able to

increase cancer detection rates.

The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.

Inclusion Criteria

All subjects:

≥50 years of age

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:

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.

Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

Exclusion Criteria

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] of 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 transplant.

Contacts

Research Nurse: Karen Jones (x2031) Karen.Jones4@lthtr.nhs.uk

Link to EDGE

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