Clinical trial · Observational
Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual difficulties
Summary
Brief summary (as posted)
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
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 |
|---|---|---|---|
| Neoplasms, Non-hematologic - Stage I-III | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Early stage neoplasm
- description
- Patients with stage I-III early stage non-hematologic neoplasm
- label
- Healthy Control
- description
- Patients undergoing surgery for a non-malignant condition with no prior history of malignancy.
Primary outcomes (2)
- measure
- Detection of signal in the presence of active neoplasm
- timeFrame
- 2 years
- description
- To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.
- measure
- Determine change in signal after surgery
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. For all participants: * Age 18 years or older * Able to understand and grant informed consent * Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery For participants with early stage solid tumors: * Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned For "healthy control" subgroup: * No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately. Exclusion Criteria: * Unable to grant informed consent or comply with all study procedures * Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).
References
Publications (0)
Data not yet available