An observational study in Non-small Cell Lung Cancer, Esophageal Cancer and Gastric Cancer, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Missouri-Columbia · Observational
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.
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 620 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with the diagnosis of a solid cancer of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 5 years
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)
Time frame: 5 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jul 2016 (actual). Primary completion is estimated for Dec 2027, 137 months after the start.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 137 months is above that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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