Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer

NCT03724994 | Completed

• 1 other identifier: CHAMP
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that started Sept 1 2018. Patients diagnosed with pancreatic or other periampullary adenocarcinoma undergoing adjuvant och palliative chemotherapy are invited to participate. The study will examine the tumors' molecular dynamics and how this may change over time and with treatment. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life. We estimate that 90 patients will be included in the study per year.

Conditions

Periampullary Adenocarcinoma; Periampullary Cancer; Pancreatic Cancer

Keywords

chemotherapy; adjuvant; palliative; prognostic; predictive; immune response; biomarkers; mutations; cytokines; immune cell signatures

Outcome Measures

Primary Outcomes (1)

• Overall survival

  months

  5 years

Secondary Outcomes (2)

• Time to progression

  5 years

• Disease specific survival

  5 years

Study Arms (1)

Study cohort

All patients with periampullary adenocarcinoma or pancreatic cancer receiving palliative or adjuvant chemotherapy (e.g. Gemcitabine, Folfirinox, etc.) in the Department of Oncology, Skåne University hospital, Malmö and Lund

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Adjuvant or palliative chemotherapy according to national guidelines

Also known as: Folfirinox, Gemcitabine - nab-paclitaxel, Fluorouracil, FLOX, 5-FU, 5-Fluorouracil

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate.

You may qualify if:

• Patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö.

You may not qualify if:

• patients having another concomitant life-threatening disease and
• patients who are unable to receive chemotherapy.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Department of Oncology, Skåne University Hospital

Malmo, Skåne County, 214 28, Sweden

Location

Related Publications (5)

• Petersson A, Andersson N, Hau SO, Eberhard J, Karlsson J, Chattopadhyay S, Valind A, Elebro J, Nodin B, Leandersson K, Gisselsson D, Jirstrom K. Branching Copy-Number Evolution and Parallel Immune Profiles across the Regional Tumor Space of Resected Pancreatic Cancer. Mol Cancer Res. 2022 May 4;20(5):749-761. doi: 10.1158/1541-7786.MCR-21-0986.

  PMID: 35149544 BACKGROUND

• Olsson Hau S, Williamsson C, Andersson B, Eberhard J, Jirstrom K. Sex and gender differences in treatment intention, quality of life and performance status in the first 100 patients with periampullary cancer enrolled in the CHAMP study. BMC Cancer. 2023 Apr 11;23(1):334. doi: 10.1186/s12885-023-10720-w.

  PMID: 37041522 RESULT

• Hau SO, Svensson M, Petersson A, Eberhard J, Jirstrom K. Trajectories of immune-related serum proteins and quality of life in patients with pancreatic and other periampullary cancer: the CHAMP study. BMC Cancer. 2023 Nov 7;23(1):1074. doi: 10.1186/s12885-023-11562-2.

  PMID: 37936126 RESULT

• Hau SO, Petersson A, Nodin B, Karnevi E, Boman K, Williamsson C, Eberhard J, Leandersson K, Gisselsson D, Heby M, Jirstrom K. Chemotherapy, host response and molecular dynamics in periampullary cancer: the CHAMP study. BMC Cancer. 2020 Apr 15;20(1):308. doi: 10.1186/s12885-020-06807-3.

  PMID: 32293352 RESULT

• Petersson A, Svensson M, Hau SO, Bergstrom R, Lindberg J, Mayrhofer M, Chattopadhyay S, Eberhard J, Heidenblad M, Leandersson K, Gisselsson D, Jirstrom K. Reliable on-treatment prognostication and target identification with a customized assay for circulating tumor DNA in patients with newly diagnosed pancreatic cancer. Sci Rep. 2025 Oct 3;15(1):34481. doi: 10.1038/s41598-025-22369-5.

  PMID: 41044171 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples (for circulating tumor DNA) and serum samples (for cytokines) Tumor cytology and/or tumor biopsy for biomarkers and mutations.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; folfirinox; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones

Study Officials

• Karin Jirström, Professor

  Lund University

  STUDY CHAIR

• Karin Leandersson, Professor

  Lund University

  STUDY CHAIR

• Margareta Heby, MD

  Lund University

  STUDY CHAIR

• Sofie Olsson Hau, MD

  Lund University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: October 30, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

SE (1)