Clinical trial · Observational
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
NCT02838836CI-TRIAL-00110067recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Study sample collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study sample collection
- description
- Blood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
- interventionNames
- Procedure: Study sample collection
Primary outcomes (1)
- measure
- CTC/DTC numbers measured in blood, urine and bone marrow samples will be correlated with patient outcome
- timeFrame
- 5 years
- description
- 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
Secondary outcomes (1)
- measure
- ctDNA characteristics will be correlated with survival data
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSuvilesh 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. PMID 35279152