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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03662204
Other study ID # 2018-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2018
Est. completion date November 1, 2019

Study information

Verified date September 2018
Source Exact Sciences Corporation
Contact Alexandra Massoud
Phone 608-957-5652
Email amassoud@exactsciences.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Subjects will have been recently diagnosed with an untreated solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date November 1, 2019
Est. primary completion date September 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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.

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.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin 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.

Study Design


Related Conditions & MeSH terms

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Kidney Cancer
  • Kidney Neoplasms
  • Liver Cancer
  • Liver Neoplasms
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pelvic Neoplasms
  • Prostate Cancer
  • Renal Pelvis Cancer
  • Stomach Cancer
  • Stomach Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cancer
  • Uterine Neoplasms

Intervention

Other:
Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

Country Name City State
United States Seattle Urology Research Center Burien Washington
United States CARTI Cancer Center Little Rock Arkansas
United States Sun Research Institute San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomarker Evaluation Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers. Point in time (one day) blood collection at enrollment
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