Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification
Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition
This study will follow people with chronic pancreatitis, people with pancreatic cancer, and healthy volunteers. The goal is to better understand why some people with chronic pancreatitis may later develop pancreatic cancer.
Participants will provide blood samples and health information. Some participants may also provide tissue samples if these are available during routine medical care. The study team will look for changes in the immune system, genes, medical images, and clinical information that may be linked to the development of pancreatic cancer.
People with chronic pancreatitis will be followed over time. The information collected in this study may help researchers develop a model to identify patients with chronic pancreatitis who have a higher risk of pancreatic cancer.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Chronic pancreatitis is considered an important precancerous condition for pancreatic ductal adenocarcinoma, but the immune changes associated with malignant transformation remain incompletely understood. This prospective observational cohort study will enroll healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma at Changhai Hospital.
The study will collect standardized clinical information, laboratory data, abdominal CT or MRI imaging data, peripheral blood samples, and, when available, tissue samples. Peripheral blood samples will be used for immune repertoire profiling, including T-cell receptor and B-cell receptor sequencing. Additional analyses may include antibody repertoire profiling, germline genetic testing, single-cell sequencing, spatial transcriptomics, and multiplex immunofluorescence in selected representative cases.
Patients with chronic pancreatitis will undergo longitudinal follow-up approximately every 6 to 12 months. The study will compare immune repertoire features across healthy controls, chronic pancreatitis, and pancreatic ductal adenocarcinoma, and will evaluate dynamic immune changes during disease progression. The collected immune, genetic, imaging, and clinical data will be integrated to develop and validate an artificial intelligence-based risk stratification model for identifying patients with chronic pancreatitis who may be at increased risk of pancreatic cancer. Participant enrollment and baseline sample collection are planned to be completed by June 2028. Follow-up, data processing, model development, and final data collection are planned to continue through December 2028.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Zhuan Liao, PhD
- Puhelinnumero: +86-21-31161001
- Sähköposti: zhuanleo@126.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort.
Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.
Kuvaus
Inclusion Criteria:
- Adults aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
- Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
- Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
- Willing to provide blood samples and relevant clinical information.
- For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.
Exclusion Criteria:
- Unable or unwilling to provide written informed consent.
- Unable to provide required clinical information or biological samples.
- Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
- Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
- Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
Healthy Controls
Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts.
|
|
Chronic Pancreatitis
Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort.
This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk.
|
|
Pancreatic Ductal Adenocarcinoma
Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
Aikaikkuna: Baseline and every 6 to 12 months for up to 30 months after enrollment
|
Peripheral blood T-cell receptor and B-cell receptor immune repertoire features will be measured from blood samples.
Features will include clonotype diversity, clonal expansion, V/J gene usage, CDR3 sequence characteristics, B-cell receptor somatic hypermutation, and shared immune clonotype clusters.
These features will be compared across healthy controls, participants with chronic pancreatitis, and participants with pancreatic ductal adenocarcinoma, and longitudinal changes will be evaluated in participants with chronic pancreatitis.
|
Baseline and every 6 to 12 months for up to 30 months after enrollment
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis
Aikaikkuna: Baseline and follow-up data collected up to 30 months after enrollment
|
A risk stratification model will be developed using immune repertoire, germline genetic, imaging, and clinical features to identify participants with chronic pancreatitis who may be at increased risk of pancreatic cancer.
Model performance will be assessed using discrimination, calibration, sensitivity, specificity, and other predictive performance measures.
|
Baseline and follow-up data collected up to 30 months after enrollment
|
|
Number of Participants With Chronic Pancreatitis Who Develop Pancreatic Ductal Adenocarcinoma
Aikaikkuna: From enrollment to the last scheduled follow-up, up to 30 months
|
The number of participants with chronic pancreatitis who develop pancreatic ductal adenocarcinoma during follow-up will be recorded.
The diagnosis will be based on clinical evaluation, imaging findings, pathology when available, and follow-up information.
|
From enrollment to the last scheduled follow-up, up to 30 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Zhuan Liao, PhD, Changhai Hospital, Naval Medical University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Endokriinisen järjestelmän sairaudet
- Patologiset prosessit
- Neoplasmat sivustoittain
- Neoplasmat
- Krooninen sairaus
- Sairauden ominaisuudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Endokriinisten rauhasten kasvaimet
- Haiman sairaudet
- Patologiset tilat, merkit ja oireet
- Haimatulehdus
- Haiman kasvaimet
- Haimatulehdus, krooninen
Muut tutkimustunnusnumerot
- CHEC2026-120
- 82541011 (Muu apuraha/rahoitusnumero: National Natural Science Foundation of China)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .