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

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ClinicalTrials.gov Identifier: NCT03662204
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

August 30, 2018
September 7, 2018
February 7, 2019
August 23, 2018
September 6, 2019   (Final data collection date for primary outcome measure)
Biomarker Evaluation [ Time Frame: Point in time (one day) blood collection at enrollment ]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
Biomarker Evaluation [ Time Frame: Point in time blood collection at enrollment ]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
Complete list of historical versions of study NCT03662204 on ClinicalTrials.gov Archive Site
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Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
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.
Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any 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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Approximately 3750 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer
Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
  • Breast
    Subjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Lung
    Subjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Colorectal
    Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Prostate
    Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Bladder
    Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Uterine
    Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Kidney & Renal Pelvis
    Subjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Pancreatic
    Subjects with clinically confirmed pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Liver
    Subjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Stomach
    Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Ovarian
    Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
  • Esophageal
    Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
    Intervention: Other: Blood Sample Collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3750
3000
November 1, 2019
September 6, 2019   (Final data collection date for primary outcome measure)

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.

    OR

    Subject has suspicion of a primary malignancy of 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.

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Alexandra Massoud 608-957-5652 amassoud@exactsciences.com
Contact: Sarit Eskritt, MS 608-720-2170 seskritt@exactsciences.com
United States
 
 
NCT03662204
2018-01
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Exact Sciences Corporation
Exact Sciences Corporation
Not Provided
Not Provided
Exact Sciences Corporation
February 2019