NCT02113683

Brief 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). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

June 21, 2018

Status Verified

March 1, 2018

Enrollment Period

4.1 years

First QC Date

April 8, 2014

Last Update Submit

June 20, 2018

Conditions

Colo-rectal CancerStomach CancerMelanomaSarcoma

Keywords

colo-rectal cancerstomach cancermelanomaMMS testtherapy monitoringSarcoma

Outcome Measures

Primary Outcomes (1)

  • active tumor growth before and after cancer therapy

    up to 36 month

Study Arms (1)

MMS test

therapy monitoring of patients with colo-rectal or stomach disease or with melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with primary diagnosis of cancer

You may qualify if:

  • Clinical diagnosis of colo-rectal cancer
  • Clinical diagnosis of stomach cancer
  • Suspected diagnosis of melanoma

You may not qualify if:

  • Colitis ulcerosa
  • Morbus Crohn
  • Cancer in time period two years before
  • Cancer therapy in time period two years before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HELIOS Klinikum Berlin-Buch, Klinik für Interdisziplinäre Onkologie

Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Colonic NeoplasmsStomach NeoplasmsMelanomaSarcoma

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft Tissue

Study Officials

  • Katja Waterstradt, PhD

    MedInnovation GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 15, 2014

Study Start

May 1, 2014

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

June 21, 2018

Record last verified: 2018-03

Locations

DE(1)