CancerProFaCoNCT00704587
Prognostic Factors for All Types of Cancer Combined
An observational study of Cancer, run by Atrium Medical Center at 2 sites in Netherlands.
Trial summary
The purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 520 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2006to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients diagnosed or suspected of cancerous conditions in the broadest sense of the word
Who may be able to join
- (Suspicion of) presence of cancer in the broadest sense of the word
- Must be able to understand and sign written informed consent
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Atrium Medical Centre Parkstad
Heerlen, Limburg, 6401 PC
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: Flow Cytometrical Analysis of the Human Immune System to Assess Tumor-related Material Piling up in Activated Macrophages in All Relevant Cancer Types.
The purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.
- Conditions
- Cancer
- Keywords
- cancer occurence, cancer recurrence, neo-adjuvant treatment response measurement
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
screening and followup
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startNov 2006
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Dennis Japink, Atrium Medical Center
- Investigators
- Dennis Japink, MD, Principal investigator, Atrium Medical Centre Parkstad, Heerlen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704587
- Sponsor's protocol ID
- ProFaCo
- Other IDs
- METC 06-p-47, MEC 08-02-030, NL14215.096.06
- Acronym
- ProFaCo
- Status last verified
- Apr 2016
- First submitted
- 23 Jun 2008
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometrical Analysis of the Human Immune System to Assess Tumor-related Material Piling up in Activated Macrophages in All Relevant Cancer Types.
- ClinicalTrials.gov ID
- NCT00704587
- Acronym / sponsor ID
- ProFaCo / ProFaCo
- Conditions
- Cancer
- Keywords
- cancer occurence, cancer recurrence, neo-adjuvant treatment response measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Atrium Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Nov 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jun 2008 (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 study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients diagnosed or suspected of cancerous conditions in the broadest sense of the word
Key inclusion criteria (2 listed)
- (Suspicion of) presence of cancer in the broadest sense of the word
- Must be able to understand and sign 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
screening and followup
Time frame: 2 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 6 Apr 2016.
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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.
Dennis Japink, MD principal investigator
Atrium Medical Centre Parkstad, Heerlen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Atrium Medical Center at 2 sites in Netherlands.
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 2 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
screening and followup (time frame: 2 years). 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 6 Apr 2016.