- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551951
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers and Subjects Undergoing Lung Cancer Screening
Study Overview
Status
Conditions
Intervention / Treatment
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. 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
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
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Recruiting
- Harry S Truman Veterans Memorial Hospital
-
Contact:
- Jussuf Kaifi, MD
- Phone Number: 573-882-6956
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Subjects with the diagnosis of a solid cancer of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma).
Lung cancer screening subjects will also be included (as defined above)
Total recruitment: 320
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients having surgery
Cancer patients undergoing surgery will have 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 |
|
Healthy subjects
Healthy control subjects will have test for circulating tumor cells, DNA alterations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of CTC/DTC in blood
Time Frame: At baseline
|
Quantify the number of CTC and DTC in urine
|
At baseline
|
Number of CTC/DTC in urine
Time Frame: At baseline
|
Quantify the number of CTC and DTC in urine
|
At baseline
|
Number of CTC/DTC in bone marrow
Time Frame: At baseline
|
Quantify the number of CTC and DTC in bone marrow
|
At baseline
|
Quantity of cfDNA in blood
Time Frame: At baseline
|
Quantify the amount of cfDNA in blood
|
At baseline
|
Quantity of cfDNA in urine
Time Frame: At baseline
|
Quantify the amount of cfDNA in urine
|
At baseline
|
Quantity of cfDNA in bone marrow
Time Frame: At baseline
|
Quantify the amount of cfDNA in bone marrow
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jussuf T Kaifi, MD, University of Missouri Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Hepatocellular
- Liver Neoplasms
Other Study ID Numbers
- 2004401-VA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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