Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
1 other identifier
observational
620
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 9, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 1, 2026
April 1, 2026
11.4 years
July 9, 2016
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CTC/DTC numbers measured in blood, urine and bone marrow samples will be correlated with patient outcome
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
5 years
Secondary Outcomes (1)
ctDNA characteristics will be correlated with survival data
5 years
Study Arms (1)
Study sample collection
Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
Interventions
Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
Eligibility Criteria
Subjects with the diagnosis of a solid cancer of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma).
You may qualify if:
- 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=20).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ellis Fischel Cancer Center, University of Missouri
Columbia, Missouri, 65212, United States
Related Publications (1)
Suvilesh KN, Nussbaum YI, Radhakrishnan V, Manjunath Y, Avella DM, Staveley-O'Carroll KF, Kimchi ET, Chaudhuri AA, Shyu CR, Li G, Pantel K, Warren WC, Mitchem JB, Kaifi JT. Tumorigenic circulating tumor cells from xenograft mouse models of non-metastatic NSCLC patients reveal distinct single cell heterogeneity and drug responses. Mol Cancer. 2022 Mar 12;21(1):73. doi: 10.1186/s12943-022-01553-5.
PMID: 35279152DERIVED
Biospecimen
Blood, bone marrow, tissue, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jussuf T Kaifi, MD, PhD
Ellis Fischel Cancer Center, University of Missouri
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Chief, Section for Thoracic Surgery
Study Record Dates
First Submitted
July 9, 2016
First Posted
July 20, 2016
Study Start
July 1, 2016
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share