Clinical trial · Observational
Radiomics-based Malnutrition for Cervical Cancer.
Development and Validation of a CT-Based Radiomics Nomogram for the Prediction of Postoperative Malnutrition in Stage IB1-IIA2 Cervical Cancer (Nutrition Helper-1).
- 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)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| There are no interventions. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Training Group
- description
- A primary cohort of eligible patients from the cancer center of Zhejiang Provincial People's Hospital is used for developing the radiomics-based nomogram prediction model. In the training cohort, a sample size of 88 was required to accept the hypothesis that the prediction accuracy of the radiomics-based nomogram model was greater than 45% with 90% power and to reject the hypothesis that the prediction accuracy rate was less than 30% with an α error of 5%. Initially, we planned to enroll 77 patients in the first stage. If 27 or more prediction accuracy rates were observed, we planned to continue to the second stage for a total of 88 patients for the analysis. Considering some deviant cases, the preplanned accrual number was set to 100 patients in the training cohort.
- interventionNames
- Other: There are no interventions.
- label
- Validation Group
- description
- An independent cohort of eligible patients is used for external validation. we are planning to enroll an additional 50 patients to further validate this radiomics-based nomogram prediction model.
- interventionNames
- Other: There are no interventions.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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. -
References
Publications (1)
- RESULTSong T, Xu H, Shi L, Yan S. Prognostic Analysis and Comparison of the 2014 and 2018 International Federation of Gynecology and Obstetrics Staging System on Overall Survival in Patients with Stage IIB-IVA Cervix Carcinoma. Int J Womens Health. 2022 Mar 6;14:333-344. doi: 10.2147/IJWH.S348074. eCollection 2022. PMID 35283649