Metastatic Pancreatic CancerPROXieNCT02983500
Patient Reported Outcomes Registry in Patient With Cancer Cachexia
An observational study of Metastatic Pancreatic Cancer and NSCLC, Metastatic, run by iOMEDICO AG at 1 site in Germany.
Trial summary
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, NSCLC, Metastatic
- How many people
- 253 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2016to 24 Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC stage III/IV) at start of their first-line palliative systemic treatment.
Who may be able to join
- Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
- Start of the first line palliative systemic treatment
- Ability to read and understand German
- Written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.
Read the detailed description
The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.
Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.
These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.
- Conditions
- Metastatic Pancreatic Cancer, NSCLC, Metastatic
- Keywords
- Patient Reported Outcome (PRO)
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with loss of > 5 % body weight
Measured: 18 months
Secondary outcomes (4)
Number of underweight patients
BMI < 20 kg/qm at start or during observation.
Measured: 12 months
General health-related quality of life assessment
At baseline, throughout and at the end of the study with SF 12 questionnaire.
Measured: 12 months
Fatigue assessment
At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).
Measured: 12 months
Cachexia assessment
At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start28 Aug 2016
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharma Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Manfred Welslau, MD, Principal investigator, Medical practise for oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983500
- Sponsor's protocol ID
- IOM-0050346
- Acronym
- PROXie
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2016
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia
- ClinicalTrials.gov ID
- NCT02983500
- Acronym / sponsor ID
- PROXie / IOM-0050346
- Conditions
- Metastatic Pancreatic Cancer, NSCLC, Metastatic
- Keywords
- Patient Reported Outcome (PRO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharma Europe Ltd.
- Study start
- 28 Aug 2016 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.
Detailed description
The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.
Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.
These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC stage III/IV) at start of their first-line palliative systemic treatment.
Key inclusion criteria (4 listed)
- Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
- Start of the first line palliative systemic treatment
- Ability to read and understand German
- Written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients with loss of > 5 % body weight
Time frame: 18 months
4 secondary outcomes
Number of underweight patients
Time frame: 12 months
General health-related quality of life assessment
Time frame: 12 months
Fatigue assessment
Time frame: 12 months
Cachexia assessment
Time frame: 12 months
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 7 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Manfred Welslau, MD principal investigator
Medical practise for oncology
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 Metastatic Pancreatic Cancer and NSCLC, Metastatic, run by iOMEDICO AG at 1 site in Germany.
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 4 inclusion and 1 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 7 Aug 2020. 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 Germany. 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?
Rate of patients with loss of > 5 % body weight (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2020.