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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

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 Type : Observational
Estimated Enrollment : 3750 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 : September 6, 2019
Estimated Study Completion Date : November 1, 2019


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 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.




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.



Information from the National Library of Medicine

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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 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.
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 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.

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


Contacts
Contact: Alexandra Massoud 608-957-5652 amassoud@exactsciences.com
Contact: Sarit Eskritt, MS 608-720-2170 seskritt@exactsciences.com

  Show 54 Study Locations
Sponsors and Collaborators
Exact Sciences Corporation

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03662204     History of Changes
Other Study ID Numbers: 2018-01
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Colorectal Neoplasms
Pancreatic Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Kidney Neoplasms
Stomach Neoplasms
Uterine Neoplasms
Pelvic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Female
Carcinoma, Renal Cell
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pancreatic Diseases
Endocrine System Diseases