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Trial record 48 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 of Patients With Solid Cancers

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ClinicalTrials.gov Identifier: NCT02838836
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : May 25, 2018
Sponsor:
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. 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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer Hepatocellular Cancer Colorectal Cancer Procedure: Study sample collection

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.

Hypothesis and Rationale:

CTCs/DTCs and cfDNA isolated from the blood, urine and bone marrow during cancer surgeries 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.

Specific Aims:

CTCs/DTCs and cfDNA isolated from cancer patients will be characterized for genetic alterations and expression of key signaling/proliferation biomarkers and grow in vivo in nude mice.

Study Design:

100 patients undergoing solid cancer surgeries will be recruited for perioperative CTC/DTC/cfDNA isolation from the blood, urine and bone marrow with innovative techniques. In addition, 10 patients undergoing similar surgeries for 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 translational cancer trial 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.


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Study Type : Observational
Estimated Enrollment : 110 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
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2021


Group/Cohort Intervention/treatment
Study sample collection
Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
Procedure: Study sample collection
Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery




Primary Outcome Measures :
  1. CTC/DTC numbers measured in blood, urine and bone marrow samples will be correlated with patient outcome [ Time Frame: 5 years ]
    CTC/DTC numbers in the blood, urine and bone marrow will be determined and correlated with survival data (presence of recurrence, death) by univariate analysis (log rank test), multivariate analysis (Cox regression) and t test/ANOVA


Secondary Outcome Measures :
  1. ctDNA characteristics will be correlated with survival data [ Time Frame: 5 years ]
    A panel of ctDNA mutations detected in the blood will be gathered in a score and correlated with survival data (presence of recurrence, death) by univariate analysis (log rank test), multivariate analysis (Cox regression)


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


Information from the National Library of Medicine

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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).
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.

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): NCT02838836


Contacts
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Contact: Jussuf T Kaifi, MD, PhD 5738828445 kaifij@health.missouri.edu
Contact: Blanche Lasta, RN 5738828445 lastal@health.missouri.edu

Locations
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United States, Missouri
Ellis Fischel Cancer Center, University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Jussuf T Kaifi, MD, PhD    573-882-8445    kaifij@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jussuf T Kaifi, MD, PhD Ellis Fischel Cancer Center, University of Missouri

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Responsible Party: Jussuf Kaifi, Assistant Professor, Chief, Section for Thoracic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02838836     History of Changes
Other Study ID Numbers: 2010166
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jussuf Kaifi, University of Missouri-Columbia:
Cancer
Circulating tumor cells (CTCs)
Disseminated tumor cells (DTCs)
Circulating tumor DNA (ctDNA)

Additional relevant MeSH terms:
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Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
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
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pancreatic Diseases
Endocrine System Diseases