Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Pancreatic Cancer; Esophageal Cancer; Non-small Cell Lung Cancer; Hepatocellular Cancer
• Intervention / Treatment: 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, 20 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.

• Study Type: Observational
• Enrollment (Estimated): 620

Contacts and Locations

• Study Contact: Name: Jussuf T Kaifi, MD, PhD; Phone Number: 5738828445; Email: kaifij@health.missouri.edu
• Study Contact Backup: Name: Blanche Lasta, RN; Phone Number: 5738828445; Email: lastal@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • Ellis Fischel Cancer Center, University of Missouri
      • Contact: Jussuf T Kaifi, MD, PhD; Phone Number: 5738828445; Email: kaifij@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

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=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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA characteristics will be correlated with survival data	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)	5 years

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Jussuf T Kaifi, MD, PhD, Ellis Fischel Cancer Center, University of Missouri

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 9, 2016
• First Submitted That Met QC Criteria: July 16, 2016
• First Posted (Estimated): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Circulating tumor cells (CTCs); Circulating tumor DNA (ctDNA); Disseminated tumor cells (DTCs)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pancreatic Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Neoplastic Processes; Esophageal Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating
• Other Study ID Numbers: 2010166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No