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).
Zhejiang Provincial People's Hospital
150 participants
Jan 31, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria9
- Patients received pelvic lymphadenectomy and radical hysterectomy, and pathological diagnosis of CC;
- Patients had stage IB1-IIA2 CC based on the 2014 FIGO staging system for cervical cancer;
- Patients received postoperative RT/CRT within one week after admission at the ZJPPH;
- Patients must have Eastern Cooperative Oncology Group performance status 0-2;
- No treatments prior to radical surgery;
- 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.
- Patient does not have a known allergy to platinum (cisplatin or carboplatin) or compounds of similar biologic composition.
- Patients must be with good compliance and agree to accept nutritional therapy;
- Informed consent signed. -
Exclusion Criteria8
- Poor image quality or visible artifacts around the L3 psoas;
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy or radiotherapy intolerable;
- Participating in other clinical trials;
- Pregnancy, breast feeding, or not adopting birth control;
- 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;
- The subject has had another active malignancy within the past five years;
- Poor image quality or visible artifacts around the L3 psoas. -
Interventions
There are no interventions.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05709769