Pharmacokinetic Studies Participation Survey

NCT00923468 | Completed

• 2 other identifiers: 08022308-C-0223
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a period of time from study participants to determine how the body handles the substance. These studies provide critical information about new drugs.
• Often, patients or parents of children in drug studies choose not to participate in optional PK studies that are part of the study protocol.
• A better understanding of why patients or families do or do not agree to participate in PK studies may help researchers make it easier for people to participate in them. Objectives:
• To learn why some people do or do not agree to participate in PK blood sampling studies. Eligibility:
• Patients 18 years of age and older and parents or guardians of children who are participating in a study of a drug that includes the option of participating in PK sampling. Design:
• Participants fill out a 2-page survey asking about why they did or did not participate in the study's PK sampling.

Conditions

Relapsed Solid Tumors; Relapsed Leukemia; Relapsed Brain Tumors

Keywords

Pharmacokinetics; Phase I Trials; Children; Relaspsed Solid Tumors; Relapsed Leukemia; Relapsed Brain Tumors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who consented within the 4 weeks prior to enrollment on this questionnaire study to a Phase 1 study that included optional PK sampling. (If the subject was a minor and a parent or legally authorized representative provided consent, subject for this questionnaire study refers to the parent). The PK questionnaire should be completed within 4 weeks of when the subject consented to the study that included optional PK sampling. (Note: The Phase 1 study need not have been a COG study).
• Subjects are eligible regardless of whether they initially agreed to participate in the PK portion and regardless of whether they actually completed the PK sampling (as long as reason for not completing the sampling was not withdrawal of consent).
• Subjects must not have withdrawn consent to the study that included optional PK sampling.
• Subjects must not have initially agreed to optional PK sampling but then withdrawn consent for sampling prior to completing the questionnaire.
• Subjects are eligible regardless of how many phase 1 or other studies they have enrolled in the past.
• Each subject may participate only once in the survey.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Leukemia; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: September 23, 2008
• Primary Completion: August 31, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-08-31

Locations

US (1)