Colo-rectal CancerMMS-TMNCT02113683
Validation of MMS Test for Cancer Monitoring
An observational study of Colo-rectal Cancer and Stomach Cancer, run by MedInnovation GmbH at 1 site in Germany.
Trial summary
The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Stomach Cancer, Melanoma
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to 20 Jun 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 with primary diagnosis of cancer
Who may be able to join
- Clinical diagnosis of colo-rectal cancer
- Clinical diagnosis of stomach cancer
- Suspected diagnosis of melanoma
Who cannot join
- Colitis ulcerosa
- Morbus Crohn
- Cancer in time period two years before
- Cancer therapy in time period two years before
Trial locations and contacts
1 site in 1 country.
Germany1 site
HELIOS Klinikum Berlin-Buch, Klinik für Interdisziplinäre Onkologie
Berlin, 13125
About this study
Official title: Validation of MMS Test to Detect Active Tumor Growth of Different Cancer Types Before and After Therapy, as Well as for Subsequent Relapse Control in Comparison to Conventional Methods
The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.
- Conditions
- Colo-rectal Cancer, Stomach Cancer, Melanoma, Sarcoma
- Keywords
- colo-rectal cancer, stomach cancer, melanoma, MMS test, therapy monitoring, Sarcoma
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Melanoma, Sarcoma
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 |
|---|---|---|
| MMS test | therapy monitoring of patients with colo-rectal or stomach disease or with melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
active tumor growth before and after cancer therapy
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Why it stopped: insufficient recruitment on the part of clinic; study will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedInnovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helios Klinikum Berlin-Buch
- Responsible party
- Sponsor
- Investigators
- Katja Waterstradt, PhD, Principal investigator, MedInnovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113683
- Sponsor's protocol ID
- MMS-tm14
- Acronym
- MMS-TM
- Status last verified
- Mar 2018
- First submitted
- 8 Apr 2014
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of MMS Test to Detect Active Tumor Growth of Different Cancer Types Before and After Therapy, as Well as for Subsequent Relapse Control in Comparison to Conventional Methods
- ClinicalTrials.gov ID
- NCT02113683
- Acronym / sponsor ID
- MMS-TM / MMS-tm14
- Conditions
- Colo-rectal Cancer, Stomach Cancer, Melanoma, Sarcoma
- Keywords
- colo-rectal cancer, stomach cancer, melanoma, MMS test, therapy monitoring, Sarcoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment on the part of clinic; study will not resume
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MedInnovation GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Helios Klinikum Berlin-Buch
- Study start
- May 2014
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 15 Apr 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 study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMS test | – | –therapy monitoring of patients with colo-rectal or stomach disease or with melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with primary diagnosis of cancer
Key inclusion criteria (3 listed)
- Clinical diagnosis of colo-rectal cancer
- Clinical diagnosis of stomach cancer
- Suspected diagnosis of melanoma
Key exclusion criteria (4 listed)
- Colitis ulcerosa
- Morbus Crohn
- Cancer in time period two years before
- Cancer therapy in time period two years before
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
active tumor growth before and after cancer therapy
Time frame: up to 36 month
Results and safety
The study was stopped early (reason given: insufficient recruitment on the part of clinic; study will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
Katja Waterstradt, PhD principal investigator
MedInnovation GmbH
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 Colo-rectal Cancer and Stomach Cancer, run by MedInnovation 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 4 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: stopped early, as of the sponsor's last update on 21 Jun 2018. 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 was stopped early (reason given: insufficient recruitment on the part of clinic; study will not resume). Results are not available in the source record.
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?
active tumor growth before and after cancer therapy (time frame: up to 36 month). 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 21 Jun 2018.