Relapsed Solid TumorsNCT00923468
Pharmacokinetic Studies Participation Survey
An observational study of Relapsed Solid Tumors and Relapsed Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed Solid Tumors, Relapsed Leukemia, Relapsed Brain Tumors
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2008to 31 Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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- Subjects must not have withdrawn consent to the study that included optional PK sampling.
- Subjects must not have initially agreed to optional PK sampling but then withdrawn consent for sampling prior to completing the questionnaire.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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
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.
Read more
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.
Read the detailed description
Background:
Pharmacokinetic studies provide critical information about the disposition of anticancer drugs in children. However, participation of children in the pharmacokinetic portion of phase I studies is optional when there is not prospect of direct benefit to the child.
The rate of participation in optional PK studies on COG Phase I Consortium Studies has been 60-70%.
There are no recent data on why families do or do not agree to participate in optional PK studies. Understanding families' reasons may reveal barriers to participation that could be overcome, leading to increased participation rates in optional PK sampling.
Objectives:
To use a simple 2 page survey to gather preliminary information on why parents/children agree to participate in Phase I Studies do or do not agree to participate in the voluntary pharmacokinetic (PK) portion of those studies.
Eligibility:
Subjects (greater than or equal to 18 years old) or parents/guardians of subjects who are minors who consented to Phase I studies with optional PK sampling with the previous 4 weeks.
Consent for the primary Phase I treatment protocol must be active (not withdrawn).
No limit on the number of prior Phase I studies in which the subject or subject's child participated.
Subjects may only participate in this study once.
Design:
The individual who provided consent to the treatment study that included optional PK sampling will complete a short questionnaire.
Subjects (n=50) from a convenience sample will complete and return the questionnaire.
Reasons for participating or agreeing to participate will be tabulated. Correlations between answers and subject demographics, time required by PK, need for additional IV will be sought.
Subjects will meet off study criteria when the questionnaire is returned, lost to follow up, or consent for data submission to this or the primary treatment protocol is withdrawn.
The total accrual is 50 subjects. Accrual ceiling at the POB, NCI is 25 subjects.
- Keywords
- Pharmacokinetics, Phase I Trials, Children, Relaspsed Solid Tumors, Relapsed Leukemia, Relapsed Brain Tumors
- Medical subject headings
- Leukemia, Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start23 Sep 2008
- Primary completion31 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Solid TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923468
- Sponsor's protocol ID
- 080223
- Other IDs
- 08-C-0223
- Status last verified
- 31 Aug 2009
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
- ClinicalTrials.gov ID
- NCT00923468
- Acronym / sponsor ID
- 080223
- Keywords
- Pharmacokinetics, Phase I Trials, Children, Relaspsed Solid Tumors, Relapsed Leukemia, Relapsed Brain Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Sep 2008
- Primary completion
- 31 Aug 2009 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Pharmacokinetic studies provide critical information about the disposition of anticancer drugs in children. However, participation of children in the pharmacokinetic portion of phase I studies is optional when there is not prospect of direct benefit to the child.
The rate of participation in optional PK studies on COG Phase I Consortium Studies has been 60-70%.
There are no recent data on why families do or do not agree to participate in optional PK studies. Understanding families' reasons may reveal barriers to participation that could be overcome, leading to increased participation rates in optional PK sampling.
Objectives:
To use a simple 2 page survey to gather preliminary information on why parents/children agree to participate in Phase I Studies do or do not agree to participate in the voluntary pharmacokinetic (PK) portion of those studies.
Eligibility:
Subjects (greater than or equal to 18 years old) or parents/guardians of subjects who are minors who consented to Phase I studies with optional PK sampling with the previous 4 weeks.
Consent for the primary Phase I treatment protocol must be active (not withdrawn).
No limit on the number of prior Phase I studies in which the subject or subject's child participated.
Subjects may only participate in this study once.
Design:
The individual who provided consent to the treatment study that included optional PK sampling will complete a short questionnaire.
Subjects (n=50) from a convenience sample will complete and return the questionnaire.
Reasons for participating or agreeing to participate will be tabulated. Correlations between answers and subject demographics, time required by PK, need for additional IV will be sought.
Subjects will meet off study criteria when the questionnaire is returned, lost to follow up, or consent for data submission to this or the primary treatment protocol is withdrawn.
The total accrual is 50 subjects. Accrual ceiling at the POB, NCI is 25 subjects.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Solid Tumors and Relapsed Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.