Predicting Tumor Metastasis by Employing a Target Organ/Primary Lesion Fusion Radiomics Model

NCT06202404 | Recruiting

• 1 other identifier: 2023-Seedandsoil01
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

A pre-metastatic target organ/primary lesion fusion radiomics model was developed based on the "soil-seed" theory to predict comman tumor metastasis in retrospective settings. To prospectively verify the performance of the target organ/primary lesion fusion radiomics model in predicting tumor metastasis patterns (brain metastasis in lung cancer, liver metastasis in colorectal cancer, lung metastasis in breast cancer), we designed this prospective observational trial.

Conditions

Metastasis; Predictive Cancer Model

Keywords

metastasis; radiomics; seed and soil theory

Outcome Measures

Primary Outcomes (1)

• brain metastasis-free survival, BMFS

  All patients were followed up regularly for at least 3 years. brain metastasis-free survival (BMFS) between the high-risk group and the low-risk group during follow-up was the primary endpoint. log-rank method was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) of brain metastases between the two groups. If the hazard ratio was less than 0.75 and the upper limit of the 95% confidence interval was less than 1, the study was considered to have met the prespecified end point.

  from enrollment to follow-up.

Secondary Outcomes (3)

• 1-year/2-year/3-year BMFS rate

  1-year/2-year/3-year from enrollment

• progression free survival

  Up to 5 years

• overall survival

  From date of treatment start until the date of death from any cause or censored at the last day that the subjects are documented to be alive, whichever came first, assessed up to 5 years

Study Arms (2)

High risk group

This is a observational study, patients will be assigned to high-risk or low-risk groups (according to a radiomics model) by the investigators. Both the patients and the treating physicians will be blinded to this procedure. No interventions excluding standard treatment procedure executed by the treating physicians.

Low risk group

This is a observational study, patients will be assigned to high-risk or low-risk groups (according to a radiomics model) by the investigators. Both the patients and the treating physicians will be blinded to this procedure. No interventions excluding standard treatment procedure executed by the treating physicians.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study was a prospective observational study. According to the inclusion and exclusion criteria, patients with stage III-IV lung cancer without brain metastasis, colorectal cancer without liver metastasis, and breast cancer without lung metastasis were enrolled. The baseline imaging data and other clinical information were systematically collected, and the enrolled patients were assigned to the high-risk group and the low-risk group according to the radiomics prediction model. The radiomics prediction performance of the previously established metastatic target organ/primary lesion fusion radiomics model for tumor metastasis was regularly followed up and prospectively verified.

You may qualify if:

• ECOG performance status score 0-2;
• Histologically or cytologically confirmed stage III-IV NSCLC;
• If the baseline pathology is adenocarcinoma, driver gene testing (at least EGFR/ALK/ROS1/KRAS/MET) should be performed;
• Complete imaging data of baseline stage (contrast-enhanced MR For lung cancer, contrast-enhanced MR/CT for colorectal cancer, and chest CT for breast cancer);
• No target organ metastasis on baseline imaging (no brain/liver/lung metastasis for lung cancer/colorectal cancer/breast cancer, respectively);
• Patients received at least one systemic therapy (chemotherapy, targeted therapy, immunotherapy, etc.) and received regular follow-up;
• Regular follow-up during and after treatment;
• Life expectancy ≥6 months;

You may not qualify if:

• Patients with indeterminate pathological type;
• Patients without baseline imaging data before treatment;
• Baseline imaging examination showed that the corresponding target organ had metastasis (lung cancer/colorectal cancer/breast cancer corresponding to brain/liver/lung metastasis);
• patients who cannot or refuse to receive regular imaging follow-up;
• Combined history of other malignant tumors;
• Medical examination or clinical findings or other uncontrollable conditions that the investigator considers may interfere with the results or increase the risk of treatment complications for the patient; ,
• Lactating or pregnant women;
• Receiving other long-term medications that may affect disease progression as assessed by a physician.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Related Publications (1)

• Chu X, Gong J, Yang X, Ni J, Gu Y, Zhu Z. A "Seed-and-Soil" Radiomics Model Predicts Brain Metastasis Development in Lung Cancer: Implications for Risk-Stratified Prophylactic Cranial Irradiation. Cancers (Basel). 2023 Jan 2;15(1):307. doi: 10.3390/cancers15010307.

  PMID: 36612303 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiao Chu

CONTACT

15821383376; chuxiao@sibs.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (2)