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Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification

2026年5月21日 更新者：Zhuan Liao、Changhai Hospital

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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

800

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Zhuan Liao, PhD
  • 電話番号：+86-21-31161001
  • メール：zhuanleo@126.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Changhai Hospital

捜査官

  • 主任研究者：Zhuan Liao, PhD、Changhai Hospital, Naval Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月28日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CHEC2026-120
  • 82541011 (その他の助成金/資金番号：National Natural Science Foundation of China)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data underlying the main study results may be shared under controlled access. Shared data may include de-identified demographic and clinical data, laboratory results, imaging-related data or metadata, germline genetic testing results, immune repertoire-derived data, and longitudinal follow-up outcomes. Data will be shared together with relevant metadata or a data dictionary when permitted by the ethics approval, informed consent, and institutional data-sharing policies.

IPD 共有時間枠

Beginning 12 months after publication of the main study results and available for 5 years.

IPD 共有アクセス基準

Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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