CarcinomaNCT02303353
Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy
An observational study of Carcinoma, run by SPGO Research Mannheim GmbH at 1 site in Germany.
Trial summary
The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Sep 2018
- 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: Patients suffering from carcinoma which are treated in practices (ambulant therapy)
Who may be able to join
- 18 years and older
- Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma)
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.
- Conditions
- Carcinoma
- Keywords
- Breast cancer, Ovarian cancer, Lung cancer, Colon cancer, Gastric cancer, Pancreatic cancer, Rectum cancer, Plasmacytoma
- Medical subject headings
- Carcinoma, Breast Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Patients suffering from a carcinoma (either breast, ovarian, lung, colon, stomach, pancreas, rectum or plasmacytoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation)
Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation
Measured: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Secondary outcomes (1)
Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies)
Number and type of adverse reactions and applied counter measures / therapies
Measured: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPGO Research Mannheim GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AKP Freiburg GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303353
- Sponsor's protocol ID
- REGONKO-01
- Status last verified
- Feb 2017
- First submitted
- 3 Nov 2014
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy
- ClinicalTrials.gov ID
- NCT02303353
- Acronym / sponsor ID
- REGONKO-01
- Conditions
- Carcinoma
- Keywords
- Breast cancer, Ovarian cancer, Lung cancer, Colon cancer, Gastric cancer, Pancreatic cancer, Rectum cancer, Plasmacytoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- SPGO Research Mannheim GmbHIndustry (pharma, biotech, devices)
- Collaborators
- AKP Freiburg GmbH
- Study start
- Oct 2013
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Nov 2014 (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.
The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | –Patients suffering from a carcinoma (either breast, ovarian, lung, colon, stomach, pancreas, rectum or plasmacytoma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from carcinoma which are treated in practices (ambulant therapy)
Key inclusion criteria (3 listed)
- 18 years and older
- Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma)
- Written informed consent
Key exclusion criteria (0 listed)
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
Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation)
Time frame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation
1 secondary outcome
Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies)
Time frame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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.
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 Carcinoma, run by SPGO Research Mannheim GmbH 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilde Huber (+49 761 479 400, info@akp-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation) (time frame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 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 24 Feb 2017.