Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Jul 16, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating how tumor cells and DNA can be detected in the blood, urine, and bone marrow of patients with solid tumors, such as lung, esophageal, gastric, pancreatic, liver, and colorectal cancers. The goal is to understand how cancer spreads and to develop more personalized treatment options for patients. Researchers hope that by analyzing these samples, they can better predict the chances of cancer recurrence after surgery and improve overall patient care.

To participate, individuals must be at least 18 years old and diagnosed with a solid cancer. The trial is open to all genders and ethnicities. Some patients without any cancer history will also be included as a comparison group. Participants in this study should be able to give informed consent and have no active secondary cancers or serious blood-related issues. Those who join can expect to provide blood, urine, and bone marrow samples for testing, but no extra procedures will be performed solely for the study if they are not needed for their medical treatment.

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=20).
• • 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.
• 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.