NCT02006550

Brief Summary

Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory suggests that most tumors undergo a process of differentiation through which a relatively rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result of this cellular diversity, one or more cells within the tumor are likely to be resistant to therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the original intervention. The cellular programs driving the uncontrolled proliferation of many solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs will be effective in the treatment of cancer. The investigators' research program focuses on the elucidation of signaling mechanisms, control of cellular processes and discovery of small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental to CSCs. Our preliminary results identified a novel Notch associated protein NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human solid tumors and is required for cell survival and tumor growth in notch -dependent tumor cells. The investigators' aim is to further interrogate the link between Notch and Nack.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

8.4 years

First QC Date

December 4, 2013

Last Update Submit

March 28, 2019

Conditions

Keywords

WntNotchHedgehogTumor Sample

Outcome Measures

Primary Outcomes (1)

  • Identify and isolate the cancer stem cell populations from primary tumor samples.

    5 years

Eligibility Criteria

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

These are samples derived from discarded tissue obtained through the routine surgical resection of tumors

You may qualify if:

  • Patients diagnosed with a primary cancer tumor scheduled for a surgery to remove it.

You may not qualify if:

  • Patients not diagnosed with a primary cancer scheduled for a standard of care (SOC) surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Anthony Capobianco, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

June 16, 2010

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Locations