Non Small Cell Lung CancerNCT03551951
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
An observational study of Non Small Cell Lung Cancer and Esophageal Cancer, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer
- What is being tested?
- Test for circulating tumor cells, DNA alterations
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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). Lung cancer screening subjects will also be included (as defined above) Total recruitment: 320
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harry S Truman Veterans Memorial Hospital
Columbia, Missouri, 65212
Jussuf Kaifi, MD, 5738826956
About this study
Official title: Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers and Subjects Undergoing Lung Cancer Screening
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.
Read the 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. These liquid biomarkers might also be suitable for screening purposes and early detection of in high risk subjects for lung cancer.
Hypothesis and Rationale: CTCs/DTCs and cfDNA isolated from the blood, urine and bone marrow 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 of early and advanced stages.
Specific Aims: CTCs/DTCs and cfDNA will be quantified and characterized for genetic alterations and expression of key signaling/proliferation biomarkers and grow in vivo in nude mice.
Study Design: 100 cancer patients will be recruited for CTC/DTC/cfDNA isolation from the blood, urine and bone marrow with innovative techniques. Bone marrow will be drawn only perioperatively in cancer patients undergoing anesthesia for surgery. 200 high-risk individuals undergoing lung cancer screening with a low dose CT will also be included for blood and urine collection to test the usefulness of these liquid biomarkers for early detection of lung cancer. In addition, 20 individuals with 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 study 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, and improve early detection.
- Conditions
- Non Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Hepatocellular Cancer, Colorectal Cancer
- Being tested
- Test for circulating tumor cells, DNA alterations
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test for circulating tumor cells, DNA alterationsDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Patients having surgery | Cancer patients undergoing surgery will have test for circulating tumor cells, DNA alterations Receives: Diagnostic Test: 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 Receives: Diagnostic Test: Test for circulating tumor cells, DNA alterations | |
| Healthy subjects | Healthy control subjects will have test for circulating tumor cells, DNA alterations Receives: Diagnostic Test: Test for circulating tumor cells, DNA alterations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CTC/DTC in blood
Quantify the number of CTC and DTC in urine
Measured: At baseline
Number of CTC/DTC in urine
Quantify the number of CTC and DTC in urine
Measured: At baseline
Number of CTC/DTC in bone marrow
Quantify the number of CTC and DTC in bone marrow
Measured: At baseline
Quantity of cfDNA in blood
Quantify the amount of cfDNA in blood
Measured: At baseline
Quantity of cfDNA in urine
Quantify the amount of cfDNA in urine
Measured: At baseline
Quantity of cfDNA in bone marrow
Quantify the amount of cfDNA in bone marrow
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jul 2016
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Harry S. Truman Memorial Veterans' Hospital
- Responsible party
- Principal investigator, Jussuf Kaifi, University of Missouri-Columbia
- Investigators
- Jussuf T Kaifi, MD, Principal investigator, University of Missouri Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551951
- Sponsor's protocol ID
- 2004401-VA
- Status last verified
- Oct 2025
- First submitted
- 23 May 2018
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data will be shared