CompletedNot applicableNCT03662204
Official study title

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Study summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBlood Sample Collection

The study team can explain what participation involves.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 1, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?119 U.S. locations

Locations may change over time.

Who runs it?Exact Sciences Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Exact Sciences Corporation
Interventions being studied
Other: Blood Sample Collection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Subject is male or female \> 18 years of age. 2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer. OR Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging. 3. 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.

Reasons someone may not be able to joinExclusion criteria

1. Prior or concurrent cancer diagnosis defined as: 1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR 2. Recurrence of the same primary cancer within any timeframe; OR 3. 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 his or her 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic HospitalPhoenix, Arizona
  • Scottsdale Medical Imaging ResearchScottsdale, Arizona
  • Arizona Clinical Research Center, Inc.Tucson, Arizona
  • Urological Associates of Southern Arizona, PCTucson, Arizona
  • Mercy Research-Fort SmithFort Smith, Arkansas
  • Genesis Cancer CenterHot Springs, Arkansas
  • NEA Fowler Family Center for Cancer CareJonesboro, Arkansas
  • CARTI Cancer CenterLittle Rock, Arkansas
  • John Muir Clinical ResearchConcord, California
  • Marin Cancer CareGreenbrae, California
  • Alliance Research CentersLaguna Hills, California
  • Office of John Homan, MDNewport Beach, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 1, 2022. Always confirm current availability with the study team.

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