Periampullary AdenocarcinomaCHAMPNCT03724994
Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer
An observational study of Periampullary Adenocarcinoma and Periampullary Cancer, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Adenocarcinoma, Periampullary Cancer, Pancreatic Cancer
- What is being tested?
- Gemcitabine
- How many people
- 201 participants
- Where
- 1 siteSweden
- Study dates
- 30 Oct 2018to 31 Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients having another concomitant life-threatening disease and
- patients who are unable to receive chemotherapy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Oncology, Skåne University Hospital
Malmö, Skåne County, 214 28
About this study
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.
Read the detailed description
The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All 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. The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and 2. patients who are unable to receive chemotherapy will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form.
The treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction.
- Being tested
- Gemcitabine
- Keywords
- chemotherapy, adjuvant, palliative, prognostic, predictive, immune response, biomarkers, mutations, cytokines, immune cell signatures
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Folfirinox, Gemcitabine - nab-paclitaxel, Fluorouracil, FLOX
Adjuvant or palliative chemotherapy according to national guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
months
Measured: 5 years
Secondary outcomes (2)
Time to progression
months
Measured: 5 years
Disease specific survival
months
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start30 Oct 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Periampullary AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Jirström, Professor, Study chair, Lund UniversityKarin Leandersson, Professor, Study chair, Lund UniversityMargareta Heby, MD, Study chair, Lund UniversitySofie Olsson Hau, MD, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724994
- Sponsor's protocol ID
- CHAMP
- Acronym
- CHAMP
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2018
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35149544Olsson 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.
PubMed 37041522Hau 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.
PubMed 37936126Hau 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.
PubMed 32293352Petersson 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.
PubMed 41044171
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer
- ClinicalTrials.gov ID
- NCT03724994
- Acronym / sponsor ID
- CHAMP / CHAMP
- Keywords
- chemotherapy, adjuvant, palliative, prognostic, predictive, immune response, biomarkers, mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All 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. The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and 2. patients who are unable to receive chemotherapy will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form.
The treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Drug: GemcitabineAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- patients having another concomitant life-threatening disease and
- patients who are unable to receive chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: Folfirinox, Gemcitabine - nab-paclitaxel, Fluorouracil, FLOXAdjuvant or palliative chemotherapy according to national guidelines | Drug | Study cohort |
Primary outcome
Overall survival
Time frame: 5 years
months
2 secondary outcomes
Time to progression
Time frame: 5 years
Disease specific survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 35149544Petersson 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.
- Results publication: PubMed 37041522Olsson 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.
- Results publication: PubMed 37936126Hau 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.
- Results publication: PubMed 32293352Hau 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.
- Derived from this study: PubMed 41044171Petersson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Jirström, Professor study chair
Lund University
Karin Leandersson, Professor study chair
Lund University
Margareta Heby, MD study chair
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periampullary Adenocarcinoma and Periampullary Cancer, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724994, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.