NCT03551951 · University of Missouri-Columbia
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
What this study is about
Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage.
View original scientific description
Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.
Interventions
DIAGNOSTIC_TEST
Test for circulating tumor cells, DNA alterations
Primary outcome measures
Number of CTC/DTC in blood
Time frame: At baseline
Quantify the number of CTC and DTC in urine
Number of CTC/DTC in urine
Time frame: At baseline
Quantify the number of CTC and DTC in urine
Number of CTC/DTC in bone marrow
Time frame: At baseline
Quantify the number of CTC and DTC in bone marrow
Quantity of cfDNA in blood
Time frame: At baseline
Quantify the amount of cfDNA in blood
Quantity of cfDNA in urine
Time frame: At baseline
Quantify the amount of cfDNA in urine
Quantity of cfDNA in bone marrow
Time frame: At baseline
Quantify the amount of cfDNA in bone marrow
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbia, Missouri
Collaborators
Harry S. Truman Memorial Veterans' Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2025 · Source of record for eligibility and locations