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

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ClinicalTrials.gov Identifier: NCT03551951
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : September 4, 2018
Sponsor:
Collaborator:
Harry S. Truman Memorial Veterans' Hospital
Information provided by (Responsible Party):
Jussuf Kaifi, University of Missouri-Columbia

Tracking Information
First Submitted Date May 23, 2018
First Posted Date June 11, 2018
Last Update Posted Date September 4, 2018
Actual Study Start Date July 1, 2016
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2018)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
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
Brief 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, lymphocyte DNA, urine, bone marrow, cancer tissue, healthy tissue
Sampling Method Non-Probability Sample
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

Condition
  • Non Small Cell Lung Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Hepatocellular Cancer
  • Colorectal Cancer
Intervention Diagnostic Test: Test for circulating tumor cells, DNA alterations
Study Groups/Cohorts
  • Patients having surgery
    Cancer patients undergoing surgery will have test for circulating tumor cells, DNA alterations
    Intervention: 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

    Intervention: Diagnostic Test: Test for circulating tumor cells, DNA alterations
  • Healthy subjects
    Healthy control subjects will have test for circulating tumor cells, DNA alterations
    Intervention: Diagnostic Test: Test for circulating tumor cells, DNA alterations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 7, 2018)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2026
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jussuf T Kaifi, MD 5738146565 jussuf.kaifi@va.gov
Contact: Jussuf T Kaifi, MD 5738146565 kaifij@health.missouri.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03551951
Other Study ID Numbers 2004401-VA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: no data will be shared
Responsible Party Jussuf Kaifi, University of Missouri-Columbia
Study Sponsor University of Missouri-Columbia
Collaborators Harry S. Truman Memorial Veterans' Hospital
Investigators
Principal Investigator: Jussuf T Kaifi, MD University of Missouri Health Care
PRS Account University of Missouri-Columbia
Verification Date August 2018