ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors

NCT03497624 | Completed

• 1 other identifier: ALCMI-006
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.

Conditions

ROS1-fusion Positive Tumor

Outcome Measures

Primary Outcomes (1)

• The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community.

  Successful generation of at least ten (10), but no more than twenty-four (24), ROS1-fusion PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. Models can be used as a resource for clinical and translational research to understand mechanisms of resistance and develop new therapies.

  1 year

Secondary Outcomes (1)

• The secondary/exploratory objectives are to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers.

  24 months

Interventions

Biospecimens collection OTHER

Collection of tumor tissue when a participant is having a clinically-indicated biopsy or surgery for their ROS1-fusion cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with a ROS1-fusion positive cancer.

You may qualify if:

• Male or female greater than 18 years of age at the time of consent.
• Confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
• A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.
• A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure.
• A minimum of 42 hours between the last dose of a tyrosine kinase inhibitor (TKI) and the time of the clinically-indicated procedure.
• Willingness to undergo all study collection procedures and follow up.
• Provision of written informed consent by the patient.
• Able to communicate (read, write and speak) in English.
• Clinically-indicated procedure to be performed within the US (including Alaska, Hawaii and Puerto Rico), Canada, England, or Israel.

You may not qualify if:

• Less than 18 years of age at time of consent.
• No confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.
• A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.
• A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.
• Receipt of systemic therapy less than 21 days from the time of the clinically-indicated procedure.
• Receipt of tyrosine kinase inhibitor less than 42 hours from the time of the clinically-indicated procedure.
• Unwilling to undergo all study collection procedures and follow up.
• Unable or unwilling to provide consent.
• Unable to communicate in English.
• Clinically-indicated procedure not scheduled within the US, Canada, England, or Israel.

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead

Study Sites (1)

ALCMI

San Carlos, California, 94040, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The tumor tissue will be used to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only.

Study Officials

• Christine Lovly, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 13, 2018
• Study Start: April 23, 2018
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (1)