Recruiting

Tumor Detection

Sponsor:

University of Missouri-Columbia

Code:

NCT02838836

Conditions

Non-small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Hepatocellular Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Study sample collection

Study Details

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.

Conditions

Non-small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Hepatocellular Cancer

Study ID

NCT02838836

Start date

Jul 1, 2016

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

620 participants

Anticipated

Interventions and Outcome Measures

Arms

Study sample collection

Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery

Interventions

Study sample collection

Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery

Primary outcome measure

  • CTC/DTC numbers measured in blood, urine and bone marrow samples will be correlated with patient outcome [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jussuf T Kaifi, MD, PhD

5738828445kaifij@health.missouri.edu

Blanche Lasta, RN

5738828445lastal@health.missouri.edu

Locations

Ellis Fischel Cancer Center, University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Jussuf T Kaifi, MD, PhD

5738828445kaifij@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Cancer
  • Circulating tumor cells (CTCs)
  • Disseminated tumor cells (DTCs)
  • Circulating tumor DNA (ctDNA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-05-01.