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Excavation and clinical verification of early warning biomarkers for hand-foot syndrome induced by capecitabine

Excavation and clinical verification of early warning biomarkers for hand-foot syndrome induced by capecitabine

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038475
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Colorectal cancer

Interventions

Gold Standard:Clinical outcome
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endogenous&#32
biomarkers&#32
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Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as colon cancer or recurrent colorectal cancer by pathological biopsy, cytology and imaging examination (diagnosis by two experienced imaging doctors). 2. Patients with at least one measurable lesion on two-dimensional imaging. 3. Patients with colorectal cancer who are willing to accept capecitabine based chemotherapy and are willing to participate in this study. 4. Patients with KPS >= 70 in physical condition assessment (can take care of themselves, but can't maintain normal life and work) 5. Patients whose survival time is expected to be more than 3 months. 6. Patients with age >= 18 years old, both male and female. 7. Patients with chemotherapy indications, including those with normal functions of organs such as heart, liver and kidney, and bone marrow without hematopoietic dysfunction. 8. Patients with complete physical examination and laboratory examination should be evaluated before treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients. 2. Patients with other malignant tumors at the same time. 3. Patients with brain metastases accompanied with neurological symptoms or poor control. 4. The patients who are allergic to fluorouracil drugs or have serious metabolisms. 5. Patients with severe infection. 6. Patients with dysphagia or active peptic ulcer, bleeding or digestive tract obstruction. 7. Patients with severe heart, liver and kidney diseases such as angina pectoris, myocardial infarction, renal failure, uremia and liver failure. 8. Patients considered unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

China

Contacts

Public ContactGao Shouhong

Shanghai Changzheng Hospital

gaoshouhong@126.com+86 13818129949

Outcome results

None listed

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