Trials / Recruiting
RecruitingNCT02838836
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 620 (estimated)
- Sponsor
- University of Missouri-Columbia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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. Hypothesis and Rationale: CTCs/DTCs and cfDNA isolated from the blood, urine and bone marrow during cancer surgeries 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. Specific Aims: CTCs/DTCs and cfDNA isolated from cancer patients will be characterized for genetic alterations and expression of key signaling/proliferation biomarkers and grow in vivo in nude mice. Study Design: 100 patients undergoing solid cancer surgeries will be recruited for perioperative CTC/DTC/cfDNA isolation from the blood, urine and bone marrow with innovative techniques. In addition, 20 patients undergoing similar surgeries for 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 translational cancer trial 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.
Conditions
- Non-small Cell Lung Cancer
- Esophageal Cancer
- Gastric Cancer
- Pancreatic Cancer
- Hepatocellular Cancer
- Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Study sample collection | Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2016-07-20
- Last updated
- 2024-10-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02838836. Inclusion in this directory is not an endorsement.