Cervical CancerNCT05709769
Radiomics-based Malnutrition for Cervical Cancer.
An observational study of Cervical Cancer and Malnutrition, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Malnutrition
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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. -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Yongshi Jia, M.D., jiayongshi@medmail.com.cn
About this study
Official title: Development and Validation of a CT-Based Radiomics Nomogram for the Prediction of Postoperative Malnutrition in Stage IB1-IIA2 Cervical Cancer (Nutrition Helper-1).
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).
Read the 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.
- Conditions
- Cervical Cancer, Malnutrition
- Being tested
- There are no interventions.
- Keywords
- Cervical Cancer, Malnutrition, Radiomics, Nomogram, Prediction
- Medical subject headings
- Uterine Cervical Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions.Other
There are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: There are no interventions. | |
| 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. Receives: Other: There are no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construction and Validation
Construction and validation of a radiomics-based nomogram for the prediction of malnutrition based on the PG-SGA scores in cervical cancer patients who underwent postoperative radiotherapy/chemoradiotherapy.
Measured: 06/30/2023-10/31/2026
Secondary outcomes (1)
GLIM criteria
Predict malnutrition assessed by the new Global Leadership Initiative on Malnutrition (GLIM) criteria.
Measured: 02/01/2023-10/31/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start31 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Song, MD, Zhejiang Provincial People's Hospital
- Investigators
- Yongshi Jia, M.D., Study chair, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709769
- Sponsor's protocol ID
- ZJPPH-RT-01
- Status last verified
- Jul 2023
- First submitted
- 18 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song T, Xu H, Shi L, Yan S. Prognostic Analysis and Comparison of the 2014 and 2018 International Federation of Gynecology and Obstetrics Staging System on Overall Survival in Patients with Stage IIB-IVA Cervix Carcinoma. Int J Womens Health. 2022 Mar 6;14:333-344. doi: 10.2147/IJWH.S348074. eCollection 2022.
PubMed 35283649
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a CT-Based Radiomics Nomogram for the Prediction of Postoperative Malnutrition in Stage IB1-IIA2 Cervical Cancer (Nutrition Helper-1).
- ClinicalTrials.gov ID
- NCT05709769
- Acronym / sponsor ID
- ZJPPH-RT-01
- Conditions
- Cervical Cancer, Malnutrition
- Keywords
- Cervical Cancer, Malnutrition, Radiomics, Nomogram, Prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | – | Other: There are no interventions.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 | – | Other: There are no interventions.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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no interventions.There are no interventions. | Other | Training Group, Validation Group |
Primary outcome
Construction and Validation
Time frame: 06/30/2023-10/31/2026
Construction and validation of a radiomics-based nomogram for the prediction of malnutrition based on the PG-SGA scores in cervical cancer patients who underwent postoperative radiotherapy/chemoradiotherapy.
1 secondary outcome
GLIM criteria
Time frame: 02/01/2023-10/31/2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 35283649Song T, Xu H, Shi L, Yan S. Prognostic Analysis and Comparison of the 2014 and 2018 International Federation of Gynecology and Obstetrics Staging System on Overall Survival in Patients with Stage IIB-IVA Cervix Carcinoma. Int J Womens Health. 2022 Mar 6;14:333-344. doi: 10.2147/IJWH.S348074. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongshi Jia, M.D. study chair
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Malnutrition, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong'en Xu, M.D. (+86-571-85893638, xuhongenzpph@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construction and Validation (time frame: 06/30/2023-10/31/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.