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An observational study on the use of chromosomal instability detection for predicting tumor recurrence and prognosis

An open-label, single-arm, observational clinical study on the detection of chromosomal instability based on circulating cell-free DNA for predicting recurrence and prognosis after treatment response in multiple cancer types.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115757
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-12-30
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced malignant tumor

Interventions

Observational group:None

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. ECOG score 0-2; 3. Diagnosed as advanced malignant tumor by histological or cytological examination and imaging, all at stage IV; 4. With objectively measurable lesions according to RECIST 1.1 criteria; 5. With clear pre-treatment imaging evidence and tumor marker results before initial anti-tumor treatment; 6. Able to regularly receive anti-tumor treatment and achieve complete remission (CR) or partial remission (PR) as evaluated by imaging; 7. After treatment response, there was a significant increase in tumor markers, but imaging evaluation remained stable; 8. Participants voluntarily joined this study and signed the informed consent form; 9. Subjects with an estimated survival time of >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Subjects whose imaging evaluations show continuous progression after anti-tumor treatment; 2. Subjects with contraindications to follow-up CT/MRI examinations; 3. Subjects who refused to undergo follow-up or failed to do so; 4. Subjects with unstable systemic coexisting diseases (active infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within 6 months, cerebrovascular accident, pulmonary embolism or untreated grade 3 deep vein thrombosis (DVT) in the past, severe mental disorders requiring medication control, liver, kidney or other metabolic diseases, neuro-psychiatric disorders such as Alzheimer's disease); 5. Subjects whose accompanying diseases, as judged by the investigator, pose a serious threat to the patient's safety or affect the patient's ability to complete the study.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of UCAD test results surpass those of tumor markers in the detection of minimal residual lesions across various cancers;The sensitivity and specificity of UCAD test results are prioritized over imaging in monitoring tumor recurrence;

Secondary

MeasureTime frame
Chromosomal instability in peripheral blood cfDNA can serve as an independent prognostic factor for dynamic MRD monitoring in pan-cancer patients after achieving complete remission, significantly correlating with patient survival outcomes including PFS and OS;

Countries

China

Contacts

Public ContactZhao Zhigang

Tianjin First Central Hospital

zzhao01@tmu.edu.cn+86 186 2222 1253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026