Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
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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 :
Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : October 4, 2021
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Condition or disease | Intervention/treatment |
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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 |
Study Type : | Observational |
Estimated Enrollment : | 5000 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 : | December 31, 2021 |
Estimated Study Completion Date : | March 31, 2022 |

Group/Cohort | Intervention/treatment |
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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. |
- 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.

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.
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 |
Inclusion Criteria:
- Subject is male or female > 18 years of age.
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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.
- 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:
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Prior or concurrent cancer diagnosis defined as:
- Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
- Recurrence of the same primary cancer within any timeframe; OR
- Concurrent diagnosis of multiple primary cancers
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- 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.
- Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- 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.

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

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: | October 4, 2021 |
Last Verified: | September 2021 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
blood draw sample collection |
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 Neoplasms, Female Urologic Neoplasms Urologic Diseases Kidney Diseases Stomach Diseases Uterine Diseases |