NCT02907086

Brief Summary

Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration 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

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

July 7, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

September 13, 2016

Last Update Submit

June 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of blood samples collected

    24 months

Study Arms (2)

colorectal cancer

Other: blood collection

melanoma

Other: blood collection

Interventions

Patients will receive a research draw for circulating tumor material analysis with standard clinical labs

colorectal cancermelanoma

Eligibility Criteria

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

colorectal cancer and melanoma patients

You may qualify if:

  • The subject must be a patient at the Hospital of the University of Pennsylvania
  • Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania
  • Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania.
  • The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
  • The subject must be 18 years of age or older.

You may not qualify if:

  • The subject is not able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsMelanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mark O'Hara, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

July 7, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations