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Trial record 47 of 962 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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 3, 2018
Sponsor:
Collaborator:
Harry S. Truman Memorial Veterans' Hospital
Information provided by (Responsible Party):
Jussuf Kaifi, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer Hepatocellular Cancer Colorectal Cancer Diagnostic Test: Test for circulating tumor cells, DNA alterations

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.


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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2026


Group/Cohort 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 :
  1. Number of CTC/DTC in blood [ Time Frame: At baseline ]
    Quantify the number of CTC and DTC in urine

  2. Number of CTC/DTC in urine [ Time Frame: At baseline ]
    Quantify the number of CTC and DTC in urine

  3. Number of CTC/DTC in bone marrow [ Time Frame: At baseline ]
    Quantify the number of CTC and DTC in bone marrow

  4. Quantity of cfDNA in blood [ Time Frame: At baseline ]
    Quantify the amount of cfDNA in blood

  5. Quantity of cfDNA in urine [ Time Frame: At baseline ]
    Quantify the amount of cfDNA in urine

  6. Quantity of cfDNA in bone marrow [ Time Frame: At baseline ]
    Quantify the amount of cfDNA in bone marrow


Biospecimen Retention:   Samples With DNA
Blood, lymphocyte DNA, urine, bone marrow, cancer tissue, healthy tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551951


Contacts
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Contact: Jussuf T Kaifi, MD 5738146565 jussuf.kaifi@va.gov
Contact: Jussuf T Kaifi, MD 5738146565 kaifij@health.missouri.edu

Locations
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United States, Missouri
Harry S Truman Veterans Memorial Hospital Recruiting
Columbia, Missouri, United States, 65212
Contact: Jussuf Kaifi, MD    573-882-6956      
Sponsors and Collaborators
University of Missouri-Columbia
Harry S. Truman Memorial Veterans' Hospital
Investigators
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Principal Investigator: Jussuf T Kaifi, MD University of Missouri Health Care

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Responsible Party: Jussuf Kaifi, Assistant Professor, Chief, Thoracic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03551951     History of Changes
Other Study ID Numbers: 2004401-VA
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pancreatic Diseases
Endocrine System Diseases