Clinical trial · Observational
Pharmacokinetic Studies Participation Survey
ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed Brain Tumors | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Leukemia | Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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.
References
Publications (0)
Data not yet available