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

a study on 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 Solid Tumor

Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion

Description

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.

Details

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.

Keywords

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 blood draw sample collection Kidney Neoplasms Stomach Neoplasms Uterine Neoplasms Pelvic Neoplasms Breast Lung Colorectal Prostate Bladder Uterine Kidney & Renal Pelvis Pancreatic Liver Stomach Ovarian Esophageal

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

  1. 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.

You CAN'T join if...

  1. Prior or concurrent cancer diagnosis defined as:
  2. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
  3. Recurrence of the same primary cancer within any timeframe; OR
  4. Concurrent diagnosis of multiple primary cancers
  5. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  6. 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.
  7. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  8. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  9. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  10. 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.

Locations

  • Office of John Homan, MD accepting new patients
    Newport Beach California 92663 United States
  • Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States
  • Alliance Research Centers accepting new patients
    Laguna Hills California 92653 United States
  • UCI Department of Urology accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Exact Sciences Corporation
ID
NCT03662204
Study Type
Observational
Last Updated