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Development and Validation of a CT-Based Radiomics Nomogram for the Prediction of Postoperative Malnutrition in Stage IB1-IIA2 Cervical Cancer (Nutrition Helper-1).

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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. -

Locations
Other Locations
China
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Hong'en Xu, M.D.
xuhongenzpph@sina.com
+86-571-85893638
Backup
Huafeng Shou, M.D.
hfshou@126.com
+86-571-85893385
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Training Group
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.
Validation Group
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.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov