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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662204
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date August 30, 2018
First Posted Date September 7, 2018
Last Update Posted Date July 14, 2020
Actual Study Start Date August 23, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
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.
Original Primary Outcome Measures
 (submitted: September 5, 2018)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Official Title Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Brief 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Approximately 7500 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.
Condition
  • 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
Intervention Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
Study Groups/Cohorts
  • 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 or suspicion of 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 19, 2019)
7500
Original Estimated Enrollment
 (submitted: September 5, 2018)
3000
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 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.

Exclusion 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Dunlap, PhD 608-733-5531 sdunlap@exactsciences.com
Contact: Sarit Eskritt, MS 608-720-2170 seskritt@exactsciences.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03662204
Other Study ID Numbers 2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators Not Provided
PRS Account Exact Sciences Corporation
Verification Date July 2020