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2016-07-01
2026-12-30
2026-12-30
320
NCT03551951
University of Missouri-Columbia
University of Missouri-Columbia
OBSERVATIONAL
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-23 | N/A | 2024-09-27 |
2018-06-07 | N/A | 2024-10-01 |
2018-06-11 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Patients having surgery Cancer patients undergoing surgery will have test for circulating tumor cells, DNA alterations | DIAGNOSTIC_TEST: Test for circulating tumor cells, DNA alterations |
| : Patients not having surgery Cancer patients not undergoing surgery (but potentially other treatments) will have test for circulating tumor cells, DNA alterations. Lung cancer screening subjects | DIAGNOSTIC_TEST: Test for circulating tumor cells, DNA alterations |
| : Healthy subjects Healthy control subjects will have test for circulating tumor cells, DNA alterations | DIAGNOSTIC_TEST: Test for circulating tumor cells, DNA alterations |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of CTC/DTC in blood | Quantify the number of CTC and DTC in urine | At baseline |
| Number of CTC/DTC in urine | Quantify the number of CTC and DTC in urine | At baseline |
| Number of CTC/DTC in bone marrow | Quantify the number of CTC and DTC in bone marrow | At baseline |
| Quantity of cfDNA in blood | Quantify the amount of cfDNA in blood | At baseline |
| Quantity of cfDNA in urine | Quantify the amount of cfDNA in urine | At baseline |
| Quantity of cfDNA in bone marrow | Quantify the amount of cfDNA in bone marrow | At baseline |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jussuf T Kaifi, MD Phone Number: 5738146565 Email: jussuf.kaifi@va.gov |
Study Contact Backup Name: Jussuf T Kaifi, MD Phone Number: 5738146565 Email: kaifij@health.missouri.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
