Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Jun 7, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating how to detect cancer cells and pieces of DNA from tumors in the blood, urine, and bone marrow of patients with certain types of solid cancers, like lung, esophageal, gastric, pancreatic, hepatocellular, and colorectal cancers. The goal is to improve our understanding of how cancer spreads and to develop personalized treatments that could help patients stay cancer-free after surgery. The trial is currently recruiting adults over 18 years old, including those with a confirmed diagnosis of solid tumors and even those who do not have cancer but are undergoing surgery for other reasons.

Participants in this study will provide samples of blood, urine, and possibly bone marrow, but they won’t need to undergo extra tests or procedures solely for this trial. If you are between 55-80 years old and have a significant smoking history, you may also qualify for lung cancer screening as part of the study. It’s important to note that pregnant women and those with certain health conditions will not be eligible to participate. Overall, this trial aims to find better ways to detect and treat cancer at earlier stages to improve outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects older than 18 years.
• • Subjects of all genders and ethnicities.
• • Subjects with the diagnosis of a solid cancer (n=100) of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma).
• • Ten patients with no present suspicion and no previous history of any cancer (except basal cell cancer of the skin) that undergo surgeries for other benign indications will serve as controls (n=10).
• • In patients undergoing surgery for cancer the histopathology should preferably be pathologically proven by a previous or novel biopsy. Yet, patients with a high cancer suspicion by radiology and clinical picture that undergo cancer surgery will not be excluded. No additional biopsies, testing or interventions will be performed for the purpose of this study if the medical treatment will not require it.
• • Subjects must be capable of giving informed consent.
• • Lung cancer screening eligibility criteria (n=100): 55-80 years old, \>30 pack years smoking history, and current smoker or have quit within the last 15 years)
• Exclusion Criteria:
• • Pregnant women.
• • Subjects with the concurrent diagnosis of an active secondary (synchronous) malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or if the patient is currently being treated with chemotherapy.
• • Subjects with a hemoglobin of \<8g/dl in the morning of the procedure will be excluded.
• • In subjects who require intraoperative transfusions of \>4 units of red packed blood cells (RPBCs), no further blood will be drawn for CTC/DTC/cfDNA analysis during surgery or on postoperative day 1.
• • In patients with coagulation disorders that could lead to significant bleeding (such as hemophilia, significant thrombocytopenia) requiring prophylactic administration of coagulative products, no bone marrow aspiration will be performed.