NCT05709769 Radiomics-based Malnutrition for Cervical Cancer.
| NCT ID | NCT05709769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-01-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Loss of skeletal muscle, is one of the most prevalent symptoms of malnutrition, and has been frequently reported as a negative factor in cancer patients at any disease stage. In this study, we are planning to firstly analyze the radiomics features of psoas extracted at the level of the third lumbar vertebra (L3) and then, develop a CT-based radiomics nomogram prediction model for predicting malnutrition based on their Patient-Generated Subjective Global Assessment (PG-SGA) scores in patients with International Federation of Gynecology and Obstetrics (FIGO, 2014 version) stage IB1-IIA2 cervical cancer (CC) who received postoperative radiotherapy/chemoradiotherapy (RT/CRT).
Eligibility Criteria
Inclusion Criteria: 1. Patients received pelvic lymphadenectomy and radical hysterectomy, and pathological diagnosis of CC; 2. Patients had stage IB1-IIA2 CC based on the 2014 FIGO staging system for cervical cancer; 3. Patients received postoperative RT/CRT within one week after admission at the ZJPPH; 4. Patients must have Eastern Cooperative Oncology Group performance status 0-2; 5. No treatments prior to radical surgery; 6. Normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin of ≥ 80g/L (can be transfused with red blood cells pre-study), an white blood cell (WBC) counts of ≥ 3.0×109/L，a neutrophil count of ≥ 2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤ 1.0 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤ 2.5 UNL, Alkaline phosphatase (AKP) ≤5.0 UNL. and no major electrocardiogram abnormalities. 7. Patient does not have a known allergy to platinum (cisplatin or carboplatin) or compounds of similar biologic composition. 8. Patients must be with good compliance and agree to accept nutritional therapy; 9. Informed consent signed. - Exclusion Criteria: 1. Poor image quality or visible artifacts around the L3 psoas; 2. Prior treatments of chemotherapy or irradiation; 3. Poor bone marrow, liver and kidney functions, which would make chemotherapy or radiotherapy intolerable; 4. Participating in other clinical trials; 5. Pregnancy, breast feeding, or not adopting birth control; 6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities; 7. The subject has had another active malignancy within the past five years; 8. Poor image quality or visible artifacts around the L3 psoas. -
Contact & Investigator
Yongshi Jia, M.D.
STUDY CHAIR
Zhejiang Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT05709769 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05709769 currently recruiting?
Yes, NCT05709769 is actively recruiting participants. Contact the research team at xuhongenzpph@sina.com for enrollment information.
Where is the NCT05709769 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05709769 clinical trial?
NCT05709769 is sponsored by Zhejiang Provincial People's Hospital. The principal investigator is Yongshi Jia, M.D. at Zhejiang Provincial People's Hospital. The trial plans to enroll 150 participants.
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