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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662204
Recruitment Status : Suspended (COVID-19)
First Posted : September 7, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Description
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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.

Condition or disease Intervention/treatment
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

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 Design
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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662204


Locations
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Sponsors and Collaborators
Exact Sciences Corporation
More Information
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03662204    
Other Study ID Numbers: 2018-01
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exact Sciences Corporation:
blood draw
sample collection
Additional relevant MeSH terms:
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Kidney Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Pelvic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urologic Neoplasms
Urologic Diseases
Kidney Diseases
Stomach Diseases
Uterine Diseases