Clinical trial · Observational
Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.
Evaluation of Systemic Therapy and the Effectiveness of Circulating Tumor DNA (ctDNA) Assays in Monitoring Treatment Response in Patients With Metastatic Cancer Undergoing K4Care Testing
NCT06929910CI-TRIAL-00092214GS_ZKMrecruitingClinicalTrials.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)
The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- This study aims to evaluate the correlation between ctDNA clearance and treatment response in metastatic cancer:
- timeFrame
- 18 months
- description
- * ctDNA clearance during and after treatment will reflect the patient's response to the treatment regimen. * Persistent positive ctDNA during and after treatment will reflect the patient's non-response to the treatment regimen and disease progression. According to current scientific reports, this correlation is independent of cancer type and treatment regimen. Moreover, this is a preliminary, observational, and descriptive statistical study. The sample size for each cancer type depends on the actual number of patients tested at Gene Solutions. Therefore, this study is not limited to a specific cancer type; all patients with metastatic cancer will be included in the analysis (similar to others design. With an average treatment response rate in the metastatic stage of 10-50%, a sample size of 200 patients will allow us to collect data for at least 20 patients.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Pathological and imaging confirmation of metastatic or progressive stage IV cancer. * Consent to the use of their clinical data. * Diagnosis of one of the following common solid tumor types: lung, colorectal, breast, gastric, or cancer of unknown primary origin. * Prior K4Care testing to identify tumor tissue (FFPE) mutations and consent to the use of their sequencing data. Exclusion Criteria: * Refusal to participate in the study. * Absence of prior K4Care testing. * Diagnosis of early-stage cancer or hematologic malignancy. * Refusal to provide clinical information or blood samples.
References
Publications (12)
- BACKGROUNDKansara M, Bhardwaj N, Thavaneswaran S, Xu C, Lee JK, Chang LB, Madison RW, Lin F, Hsu E, Patel VK, Aleshin A, Oxnard GR, Simes J, Nimeiri H, Thomas DM. Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab. Mol Oncol. 2023 Feb;17(2):298-311. doi: 10.1002/1878-0261.13349. Epub 2022 Dec 13. PMID 36426653
- BACKGROUNDBratman SV, Yang SYC, Iafolla MAJ, Liu Z, Hansen AR, Bedard PL, Lheureux S, Spreafico A, Razak AA, Shchegrova S, Louie M, Billings P, Zimmermann B, Sethi H, Aleshin A, Torti D, Marsh K, Eagles J, Cirlan I, Hanna Y, Clouthier DL, Lien SC, Ohashi PS, Xu W, Siu LL, Pugh TJ. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020 Sep;1(9):873-881. doi: 10.1038/s43018-020-0096-5. Epub 2020 Aug 3. PMID 35121950
- BACKGROUNDCabel L, Riva F, Servois V, Livartowski A, Daniel C, Rampanou A, Lantz O, Romano E, Milder M, Buecher B, Piperno-Neumann S, Bernard V, Baulande S, Bieche I, Pierga JY, Proudhon C, Bidard FC. Circulating tumor DNA changes for early monitoring of anti-PD1 immunotherapy: a proof-of-concept study. Ann Oncol. 2017 Aug 1;28(8):1996-2001. doi: 10.1093/annonc/mdx212. PMID 28459943
- BACKGROUNDBettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094. PMID 24553385
- Shuel SL. Targeted cancer therapies: Clinical pearls for primary care. Can Fam Physician. 2022 Jul;68(7):515-518. doi: 10.46747/cfp.6807515. No abstract available.