## Protocol Section
### Identification Module
**NCT ID:** NCT04436679

**Acronym:** CaPaLong

**Brief Title:** INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

**Official Title:** INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

#### Organization Study ID Info
**ID:** 2019_29
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Lille
#### Secondary ID Infos
**Domain:** ID-RCB number,ANSM
**ID:** 2019-A02001-56
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-02

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2020-06-18
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-15
**Study First Submit QC Date:** 2020-06-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Lille

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.

### Conditions Module

**Conditions:**

- Pancreas Cancer

- Pancreatic Adenocarcinoma

**Keywords:**

- survival

- prognosis

- tissue

- pancreas cancer

### Design Module

#### Bio Spec

**Description:** tissues paraffin lumbered paraffin blocks of tissue-microarrays

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 144

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact.

**Measure:** Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.

**Time Frame:** at 2 years

#### Secondary Outcomes

**Description:** Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype.

**Measure:** Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.

**Time Frame:** at 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients \> 18 years of age at diagnosis
* Primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016
* Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma
* Tissue blocks (FFPE) available (tumour/healthy tissue)
* Affiliated to a social security scheme

Exclusion Criteria:

* Absence of Primary Cancer Tissue Blocks (PCTBs)
* Paraffin block fixed in Bouin or AFA
* Patient Refusal
* Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...).
* Patient died due to post-surgical complications (death within 30 days post-surgery).
* Surgical resection of macroscopic R2 type.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Pancreatic adenocarcinoma patients operated on between 2001 and 2016.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** emmanuelle.leteurtre@chru-lille.fr

**Name:** Emmanuelle Leteurtre, MD,PhD

**Phone:** 0320445556

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lille

**Contacts:**

***Contact 1:***

- **Phone:** 0320445962

- **Role:** CONTACT

**Country:** France

**Facility:** Hop Claude Huriez Chu Lille

**Status:** RECRUITING

**Zip:** 59037

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Lille

**Name:** Emmanuelle Leteurtre, MD,PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreas Cancer

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
