RECRUITING

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

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Conditions

Non Small Cell Lung CancerEsophageal CancerGastric CancerPancreatic CancerHepatocellular CancerColorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2016-07-01
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03551951

Participation Criteria

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects older than 18 years.
  2. * Subjects of all genders and ethnicities.
  3. * 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).
  4. * 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).
  5. * 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.
  6. * Subjects must be capable of giving informed consent.
  7. * 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)
  1. * Pregnant women.
  2. * 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.
  3. * Subjects with a hemoglobin of \<8g/dl in the morning of the procedure will be excluded.
  4. * 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.
  5. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Jussuf T Kaifi, MD
PRINCIPAL_INVESTIGATOR
University of Missouri Health Care

Study Locations (Sites)

Harry S Truman Veterans Memorial Hospital
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • Jussuf T Kaifi, MD, PRINCIPAL_INVESTIGATOR, University of Missouri Health Care

Study Record Dates

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

Study Start Date2016-07-01
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2016-07-01
Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Hepatocellular Cancer
  • Colorectal Cancer