Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples

Cancer Clinical Trial

Official title:

Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02006550
• Other study ID #: 20100200
• Status: Terminated
• Start date: June 16, 2010
• Est. completion date: October 25, 2018

Study information

• Verified date: March 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 227
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify and isolate the cancer stem cell populations from primary tumor samples.		5 years