Using imaging to predict malnutrition in cervical cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze radiomics features of the psoas muscle at the L3 vertebra level to develop a CT-based nomogram for predicting malnutrition in patients with stage IB1-IIA2 cervical cancer who have undergone postoperative radiotherapy or chemoradiotherapy. By utilizing the Patient-Generated Subjective Global Assessment (PG-SGA) scores, the study seeks to enhance early identification of malnutrition, which is crucial for improving patient outcomes. The research builds on previous findings that demonstrated the potential of radiomics in generating imaging biomarkers for clinical decision support.

Why it matters

Who can join: the full rules

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. -

Where it's running

• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Hong'en Xu, M.D.
• Email: xuhongenzpph@sina.com
• Phone: +86-571-85893638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.