NCT05709769Recruiting
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 · Last updated 20 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- 31 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05709769
What you commit to
- Study type: Observational
- Planned participants: 150
- From 31 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy or radiotherapy intolerable;
Other illness
- 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;
Other
- Poor image quality or visible artifacts around the L3 psoas;
- Participating in other clinical trials;
- Pregnancy, breast feeding, or not adopting birth control;
- Poor image quality or visible artifacts around the L3 psoas. -
Who the study is looking for
- 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. -
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.