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Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer (CHAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724994
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University

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.

Condition or disease Intervention/treatment
Periampullary Adenocarcinoma Periampullary Cancer Pancreatic Cancer Drug: Gemcitabine

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Drug: Gemcitabine
Adjuvant or palliative chemotherapy according to national guidelines
Other Names:
  • Folfirinox
  • Gemcitabine - nab-paclitaxel
  • Fluorouracil
  • FLOX
  • 5-FU
  • 5-Fluorouracil




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    months


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 5 years ]
    months

  2. Disease specific survival [ Time Frame: 5 years ]
    months


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724994


Contacts
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Contact: Karin Jirström, Professor +46 46 2220829 karin.jirstrom@med.lu.se
Contact: Maragreta Heby, MD +46 40 337892 margareta.heby@med.lu.se

Locations
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Sweden
Department of Oncology, Skåne University Hospital Recruiting
Malmö, Skåne, Sweden, 214 28
Contact: Margareta Heby, MD    +46 40 337892    margareta.heby@med.lu.se   
Contact: Karin Jirström, Professor    +46 2220829    karin.jirstrom@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
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Study Chair: Karin Jirström, Professor Lunds University
Study Chair: Karin Leandersson, Professor Lunds University
Study Chair: Margareta Heby, MD Lunds University
Study Chair: Sofie Olsson Hau, MD Lunds University

Additional Information:

Publications:

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03724994    
Other Study ID Numbers: CHAMP
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
chemotherapy
adjuvant
palliative
prognostic
predictive
immune response
biomarkers
mutations
cytokines
immune cell signatures
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Fluorouracil
Folfirinox
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs