NCT01703585

Brief Summary

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 4, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

5.6 years

First QC Date

October 5, 2012

Last Update Submit

May 8, 2018

Conditions

Colorectal CancerBreast CancerGynecological CancerMetastaticEligible for Phase I or Phase II StudyMelanoma Cancer

Keywords

genomic analysisgenometumortissuearchivalbiopsycore needlefine needleDNAgeneexpressionsequencing

Outcome Measures

Primary Outcomes (1)

  • Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.

    2 years

Secondary Outcomes (5)

  • The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%

    2 years

  • The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%

    2 years

  • Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%

    2 years

  • Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%

    2 years

  • Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%

    2 years

Study Arms (4)

metastatic breast cancer

metastatic colorectal cancer

metastatic gynecological cancer

metastatic melanoma

Eligibility Criteria

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

metastatic breast, colorectal, gynecological cancer or melanoma

You may qualify if:

  • Age ≥ 18 years.
  • Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.
  • At least one biopsiable lesion deemed medically accessible and safe to biopsy.
  • Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.
  • Fulfills local institution's laboratory parameters for tumor biopsy.
  • Willingness and ability of patient to provide signed voluntary informed consent.

You may not qualify if:

  • Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
  • Any contraindication to undergoing a biopsy procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsNeoplasm MetastasisNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lillian Siu, MD

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Bedard Philippe, MD

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 10, 2012

Study Start

October 4, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

CA(1)