Radiomics-based Malnutrition for Cervical Cancer.

Trial Title: Radiomics-based Malnutrition for Cervical Cancer.

NCT ID: NCT05709769

Condition: Cervical Cancer
Malnutrition

Conditions: Official terms:
Uterine Cervical Neoplasms
Malnutrition

Conditions: Keywords:
Cervical Cancer
Malnutrition
Radiomics
Nomogram
Prediction

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: There are no interventions.
Description: There are no interventions.
Arm group label: Training Group
Arm group label: Validation Group

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).

Detailed description: Cervical cancer is still a significant health problem worldwide. Based on the pathological findings after surgery, patients with intermediate or high risk factors for recurrence are recommended to receive adjuvant pelvic RT and/or platinum (cisplatin or carboplatin) based CRT to reduce the risk of tumor recurrence. However, around 30% of individuals with CC will still eventually develop tumor relapse, necessitating the investigation of better supportive care, like nutritional support, to improve therapeutic tolerance and reduce toxic reactions in these patients. In this respect, how to early identification of malnutrition by PG-SGA tool is crucial. Meanwhile, CT-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. In our recently accepted research (not yet publish on line, abstract available at https://www.frontiersin.org/articles/10.3389/fnut.2023.1113588/abstract), we firstly analyzed the radiomics features of psoas extracted at the level of L3 and then, developed a nomogram prediction model for patients with FIGO stage IB1-IIA2 CC who received postoperative RT/CRT. Our results demonstrated that this nomogram prediction model showed promising ability for detecting malnutrition based on their PG-SGA scores. The aim of the current study is designed to verify the prediction accuracy of the developed radiomics-based nomogram prospectively.

Criteria for eligibility:

Study pop:
After radical surgery, CC patients are recommended to undergo adjuvant pelvic RT/CRT based on their pathological risk factors. The patients are immobilized in an immobilization device prior to RT, and a scheduled abdomen-pelvis CT scan is routinely conducted to plan RT. Radiomic features are extracted from the non-enhanced CT images and used for building the nomogram prediction model.

Sampling method: Non-Probability Sample
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. -

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Provincial People's Hospital

Address:
City: Hangzhou
Zip: 310000
Country: China

Status: Recruiting

Contact:
Last name: Yongshi Jia, M.D.
Email: jiayongshi@medmail.com.cn

Start date: January 31, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Zhejiang Provincial People's Hospital
Agency class: Other

Source: Zhejiang Provincial People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05709769