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

Colorectal Cancer Clinical Trial

Official title:

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers and Subjects Undergoing Lung Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551951
• Other study ID #: 2004401-VA
• Status: Recruiting
• Start date: July 1, 2016
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: University of Missouri-Columbia
• Contact: Jussuf T Kaifi, MD
• Phone: 5738146565
• Email: jussuf.kaifi[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Background: Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. 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. These liquid biomarkers might also be suitable for screening purposes and early detection of in high risk subjects for lung cancer.

Hypothesis and Rationale: CTCs/DTCs and cfDNA isolated from the blood, urine and bone marrow undergo pheno- and/or genotype changes. CTCs/DTCs have potential for dissemination and tumor growth in vivo. Investigating the biology of liquid biomarkers in the blood, urine and bone marrow will significantly increase understanding of cancer biology of early and advanced stages.

Specific Aims: CTCs/DTCs and cfDNA will be quantified and characterized for genetic alterations and expression of key signaling/proliferation biomarkers and grow in vivo in nude mice.

Study Design: 100 cancer patients will be recruited for CTC/DTC/cfDNA isolation from the blood, urine and bone marrow with innovative techniques. Bone marrow will be drawn only perioperatively in cancer patients undergoing anesthesia for surgery. 200 high-risk individuals undergoing lung cancer screening with a low dose CT will also be included for blood and urine collection to test the usefulness of these liquid biomarkers for early detection of lung cancer. In addition, 20 individuals with benign disease will also be included as controls. CTCs/DTCs, cfDNA and cancer tissue pheno- and/or genotype analysis will be performed with different innovative techniques. Furthermore, CTCs/DTCs will be enriched, cultured and characterized. Tumor growth potential will be studied in nude mice.

Relevance: This study addresses fundamental aspects of cancer disease being the cause of death in 1 out of 4 persons in the US. Innovative CTCs/DTCs characterization can shed light on the tumor biology, and identify therapy targets. Results of this study can be fundamentally important to understanding cancer spread and development of personalized therapies, and improve early detection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Hepatocellular Cancer
• Liver Neoplasms
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Pancreatic Cancer

Intervention

Diagnostic Test:
• Test for circulating tumor cells, DNA alterations

Locations

Country	Name	City	State
United States	Harry S Truman Veterans Memorial Hospital	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Harry S. Truman Memorial Veterans' Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CTC/DTC in blood	Quantify the number of CTC and DTC in urine	At baseline
Primary	Number of CTC/DTC in urine	Quantify the number of CTC and DTC in urine	At baseline
Primary	Number of CTC/DTC in bone marrow	Quantify the number of CTC and DTC in bone marrow	At baseline
Primary	Quantity of cfDNA in blood	Quantify the amount of cfDNA in blood	At baseline
Primary	Quantity of cfDNA in urine	Quantify the amount of cfDNA in urine	At baseline
Primary	Quantity of cfDNA in bone marrow	Quantify the amount of cfDNA in bone marrow	At baseline