- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07670286
Spatial Multi-omics and Intelligent Early Warning of Pancreatic Cancer Cachexia
Spatial Multi-omics Mechanism Analysis and Multimodal Intelligent Early Warning of Cachexia in Pancreatic Cancer
The goal of this observational study is to explore the spatial multi-omics mechanism of cachexia in pancreatic cancer and construct a high-precision multimodal intelligent early warning model for its early diagnosis in pathologically confirmed pancreatic ductal adenocarcinoma patients aged ≥18 years with an expected survival of ≥1 month.
The main questions it aims to answer are: 1) Can spatial transcriptomics/metabolomics reveal the interaction mechanism between tumor microenvironment and metabolism in pancreatic cancer cachexia? 2)Can a multimodal AI early warning model be built to achieve accurate early identification of pancreatic cancer cachexia? Researchers will compare the surgical cohort and advanced cohort to see the differences in cachexia incidence and progression rules among different subgroups. Participants will complete baseline questionnaires on physical and mental state, nutrition and muscle strength, undergo imaging examinations and provide biological samples (blood, feces, tissue etc.), and receive regular follow-ups for updated questionnaires, imaging rechecks and supplementary biological sample collection until death, loss to follow-up or voluntary withdrawal.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Beijing, Kina
- Rekruttering
- Peking Union Medical College Hospital
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Kontakt:
- Ruizhe Zhu
- Telefonnummer: +86 17896014778
- E-mail: zhuruizhe@pumch.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with pathologically confirmed pancreatic ductal adenocarcinoma.
- Aged ≥18 years with an expected survival time of ≥1 month (to be assessed for the advanced cohort). Assessment criteria: Comprehensive evaluation based on the patient's radiological tumor burden, vital organ function and physical status. Specific quantitative indicators: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, or Karnofsky Performance Status (KPS) score of ≥60. For patients in the advanced cohort, the assessment shall be jointly confirmed by two attending physicians with the professional title of associate chief physician or above in combination with radiological examination results.
- Voluntarily sign the informed consent form.
Exclusion Criteria:
- Complicated with other untreated malignant tumors or severe mental disorders.
- Pregnant women or patients unable to cooperate with follow-up.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Resectable group
Patients is resectable and received surgery
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Unresectable group
Patients is unresectable
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Overall Survival
Tidsramme: Time from enrollment to all-cause death, assessed up to 3 years.
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Time from enrollment to all-cause death, assessed up to 3 years.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Cachexia-free survival
Tidsramme: Time from enrollment to cachexia diagnosis, assessed up to 3 years.
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Time from enrollment to cachexia diagnosis, assessed up to 3 years.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i det endokrine system
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Neoplasmer efter sted
- Patologiske Tilstande, Anatomiske
- Kropsvægt
- Ændringer i kropsvægt
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Muskelatrofi
- Atrofi
- Vægttab
- Tyndhed
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Neoplasmer
- Bugspytkirtel neoplasmer
- Sarkopeni
- Kakeksi
Andre undersøgelses-id-numre
- SMIPC
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Kræft i bugspytkirtlen
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West China HospitalIkke rekrutterer endnu
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