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Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA (PREDIPER)

2026年5月5日 更新者:Assistance Publique - Hôpitaux de Paris

Prédiction de la dissémination péritonéale Des Tumeurs Digestives Par étude de l'ADN Tumoral Circulant

The peritoneum is a relatively frequent metastatic site in digestive tumors (colon, stomach, pancreas) and is characterized by a poorer prognosis compared with other metastatic sites such as the lung or liver. Its dissemination pathway is complex and most often involves crossing the hemato-peritoneal barrier. This type of metastasis is difficult to visualize on imaging at an early stage, and surgical exploration may be required. In gastric cancer in particular, exploratory laparoscopy is part of the initial staging work-up for locally advanced tumors to assess the presence or absence of peritoneal metastases. It is therefore important to develop new, less invasive detection or prediction methods.

Circulating tumor DNA (ctDNA) is a promising non-invasive blood biomarker that can assist clinicians as a prognostic/predictive biomarker and/or a tool for monitoring response to anti-tumor therapies. This marker is most often assessed in plasma, but recent data suggest that tumor DNA may also be detected in other biological fluids such as peritoneal fluid. A preliminary study conducted by our team showed the ability to detect tumor DNA in peritoneal fluid from patients with peritoneal carcinomatosis of various origins, with a sensitivity of 75%. In gastric cancer, a recent meta-analysis demonstrated an increased risk of peritoneal metastases when peritoneal tumor DNA was positive (RR 13.81 [95% CI, 8.11-23.53]), as well as a reduction in 3-year recurrence-free survival (RR 5.37 [95% CI, 1.39-20.74]) and overall survival (HR 4.13 [95% CI, 1.51-11.32]).

The objective of this cohort is to evaluate the prognostic impact of circulating tumor DNA (ctDNA) in plasma and/or peritoneal fluid on the risk of developing peritoneal metastases. The primary endpoint is: Peritoneal recurrence rate according to tumor DNA positivity status (positive vs negative).

調査の概要

状態

まだ募集していません

詳細な説明

After screening, verification of inclusion and exclusion criteria, information and consent, patients will be enrolled in the study.

Several samples will be collected at different time points during patient management, in addition to samples already performed as part of routine care. No intervention or sampling will occur at a time point specifically required for research purposes. Blood and peritoneal fluid samples will always be collected concomitantly. They will then be transported to the molecular biology laboratory for initial DNA extraction. After extraction, samples will be stored at -80 °C until analysis.

The treatments offered to the patient follow standard-of-care recommendations and are not modified by participation in the study.

Three independent cohorts will be evaluated: gastric cancer, colon cancer, and pancreatic cancer.Depending on the type of cancer and the therapeutic strategy, different samples will be collected.

Systematic sampling:

Plasma: at diagnosis, at the time of surgery, in the early postoperative period, and 1 month after surgery (during the postoperative visit).

Peritoneal fluid: at the time of surgery and in the early postoperative period.

Specific sampling:

Peritoneal fluid: during pre-therapeutic exploratory laparoscopy (gastric cancer) or during diverting colostomy (obstructive colon cancer).

In total:

Gastric cancer: 3 peritoneal fluid samples and 4 blood samples.

Colon cancer: 2 peritoneal fluid samples and 3 blood samples systematically, plus 1 optional blood and peritoneal fluid sample (only in case of diverting colostomy).

Pancreatic cancer: 2 peritoneal fluid samples and 3 systematic blood samples, plus 1 optional blood sample (in case of neoadjuvant treatment).

Blood sampling:

2 EDTA tubes (molecular biology)

Peritoneal fluid sampling:

2 dry tubes (molecular biology, pathology)

For intraoperative sampling, a peritoneal washing is performed with 200 mL of 0.9% NaCl instilled into the abdominal cavity; then 50 mL are collected from the pouch of Douglas.

For the postoperative period, the sample will be collected between postoperative day 2 and day 5 directly from the drainage fluid (collected from the drain reservoir left in place at the end of surgery).

ctDNA analysis: NGS (next-generation sequencing), or high-throughput sequencing, is a molecular biology method that enables the rapid sequencing of millions of DNA molecules simultaneously and is used to identify point mutations as well as insertions, duplications, and deletions. It will be used for both plasma analysis and peritoneal fluid analysis.

研究の種類

観察的

入学 (推定)

300

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

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

All patients treated for a histologically proven, localized adenocarcinoma of gastric or pancreatic or colorectal, will be enrolled in this prospective cohort study after receiving and signed a specific consent information form.

説明

Inclusion Criteria:

  • Age > 18 years
  • Signed non-opposition form
  • For gastric cancer: histologically confirmed gastric adenocarcinoma >T2 and/or N+; for colon cancer: histologically confirmed colonic adenocarcinoma >T2; for pancreatic cancer: histologically confirmed pancreatic adenocarcinoma >T2
  • No metastases on the initial staging work-up
  • No contraindication to curative-intent surgical treatment

Exclusion Criteria:

  • Primary tumor metastatic at diagnosis
  • Presence of ascites or distant metastases
  • Synchronous cancer or prior history of cancer within the past 5 years
  • Contraindication to curative surgical treatment
  • Any patient unable to comply with the study's medical follow-up for geographic, social, or psychological reasons
  • Patients under legal guardianship/protection, or unable to read, understand, and sign the information notice and consent form
  • Patients not affiliated with the social security system

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
localized gastric cancer
resectable tumor receiving neoajuvant chemotherapy and curative gastrectomy
localized colorectal cancer
resectable tumor receiving neoajuvant chemotherapy or not and curative colectomy
localized pancreatic cancer
resectable tumor receiving neoajuvant chemotherapy or not and curative pancreatectomy

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
peritoneal progression free survival (PPFS)
時間枠:Time from the start of treatment until peritoneal recurrence assessed up to 36 months
PPFS will be evaluated according to the circulating tumor DNA in the blood and in the peritoneal fluid
Time from the start of treatment until peritoneal recurrence assessed up to 36 months

二次結果の測定

結果測定
メジャーの説明
時間枠
disease free survival (DFS)
時間枠:Time from the start of treatment until recurrence assessed up to 36 months
DFS will be evaluated according to the circulating tumor DNA in the blood and in the peritoneal fluid
Time from the start of treatment until recurrence assessed up to 36 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。

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)

2033年6月1日

研究の完了 (推定)

2033年6月1日

試験登録日

最初に提出

2026年3月10日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8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5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

医薬品およびデバイス情報、研究文書

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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