Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT03551951

Conditions

Non Small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Hepatocellular Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Test for circulating tumor cells, DNA alterations

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. 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.

Conditions

Non Small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Hepatocellular Cancer

Study ID

NCT03551951

Start date

Jul 1, 2016

Status verified date

Oct, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 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=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.
  • 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)

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

320 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients having surgery

Cancer patients undergoing surgery will have test for circulating tumor cells, DNA alterations

Patients not having surgery

Cancer patients not undergoing surgery (but potentially other treatments) will have test for circulating tumor cells, DNA alterations.

Lung cancer screening subjects

Healthy subjects

Healthy control subjects will have test for circulating tumor cells, DNA alterations

Interventions

Test for circulating tumor cells, DNA alterations

Primary outcome measure

  • Number of CTC/DTC in blood [ Time Frame: At baseline ]
  • Number of CTC/DTC in urine [ Time Frame: At baseline ]
  • Number of CTC/DTC in bone marrow [ Time Frame: At baseline ]
  • Quantity of cfDNA in blood [ Time Frame: At baseline ]
  • Quantity of cfDNA in urine [ Time Frame: At baseline ]
  • Quantity of cfDNA in bone marrow [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Jussuf T Kaifi, MD

5738146565jussuf.kaifi@va.gov

Jussuf T Kaifi, MD

5738146565kaifij@health.missouri.edu

Locations

Harry S Truman Veterans Memorial Hospital

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Jussuf Kaifi, MD

573-882-6956

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

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 2025-10-08.