NCT07685548Toborzás még nem indult
AI-Driven Tumor Response Evaluation for Solid Tumors
Development of an Artificial Intelligence-Driven Novel Response Evaluation Framework and Its Biological Characterization
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 8.
Rövid összefoglaló (regiszter, angolul)
Purpose: This study is developing and validating an artificial intelligence (AI)-driven system to evaluate tumor response using changes in total tumor volume. The goal is to determine whether this AI-based approach can better predict patient survival compared with the current standard method (RECIST), which relies on linear measurements of a few selected tumors. Participants: The study includes both retrospective and prospective cohorts. The retrospective cohort includes approximately 6,000 patients with solid tumors who received non-surgical treatment between 2015 and 2025. The prospective cohort will enroll approximately 120 patients starting in mid-2026. Study details include: Study Duration: Approximately 3 years Participation Duration: Up to 6 months for prospective participants; retrospective participants contribute existing medical records only Visit Frequency: For prospective participants, follow-up visits occur every 3 months (up to 6 months) aligned with routine clinical care Intervention: None. This is an observational study using routine clinical imaging (CT/MRI) and medical records Primary endpoints: Overall survival (OS) and progression-free survival (PFS). The study will also evaluate the feasibility and impact of AI-assisted tumor response reporting on clinical workflow and patient understanding. Participants in the prospective cohort will receive either a standard RECIST report or an AI-assisted dynamic tumor response report. This comparison is for research purposes only and does not alter standard medical care.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 6120 (tervezett)
- Első benyújtás
- 2026. jún. 28.
- Kezdés
- 2026. júl. 1.
- Elsődleges befejezés
- 2029. jún. 30.
- Fő szponzor
- Shanghai Zhongshan Hospital
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT07685548
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 6120
- 2026. júl. 1. és az elsődleges befejezés (2029. jún. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Concurrent other malignancy that cannot be distinguished from the primary study tumor.
Más betegség
- Severe underlying diseases (e.g., cardiac, pulmonary, renal insufficiency) that may significantly affect survival outcome assessment.
- Cognitive impairment or other conditions that prevent cooperation with study procedures.
- Other conditions judged by the investigator as unsuitable for study inclusion. -
Egyéb
- Imaging data incomplete or of insufficient quality for accurate segmentation or volumetric calculation.
- Key clinical information or follow-up outcome data missing.
- Treatment start or baseline time point cannot be clearly determined.
- For prospective cohort: expected inability to complete follow-up.
Kiket keres a vizsgálat
- Age ≥ 18 years, any sex.
- Radiologically or pathologically confirmed diagnosis of solid tumor.
- Received non-surgical treatment with a clearly defined treatment start date.
- Availability of baseline and at least one follow-up imaging study (CT/MRI) of sufficient quality for AI-based segmentation and volumetric analysis.
- Availability of key clinical data and follow-up outcome information.
- For retrospective cohort: prior signed informed consent for biobank donation, agreeing to donate samples and data for medical research.
- For prospective cohort: planned to receive or currently receiving non-surgical treatment, and able to provide written informed consent.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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