Unspecified Adult Solid Tumor, Protocol SpecificNCT00899691
Study of Hair Samples From Patients With Cancer
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC).
Trial summary
RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment. PURPOSE: This laboratory study is looking at hair samples from patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- protein expression analysis
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of malignancy
- Undergoing treatment at the National Cancer Institute's Clinical Center
- Must have scalp hair
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
About this study
Official title: Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples
RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment.
PURPOSE: This laboratory study is looking at hair samples from patients with cancer.
Read the detailed description
OBJECTIVES:
- Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer.
- Correlate changes in protein expression with expected changes based on planned therapy in these patients.
OUTLINE: This is a pilot, multicenter study.
Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT.
PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.
- Being tested
- protein expression analysis
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein expression analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2005
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven K. Libutti, MD, Principal investigator, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899691
- Sponsor's protocol ID
- 040138
- Other IDs
- 04-C-0138, CDR0000363803
- Status last verified
- Mar 2012
- First submitted
- 9 May 2009
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples
- ClinicalTrials.gov ID
- NCT00899691
- Acronym / sponsor ID
- 040138
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Study completion
- Oct 2008 (actual)
- First posted
- 12 May 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.
RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment.
PURPOSE: This laboratory study is looking at hair samples from patients with cancer.
Detailed description
OBJECTIVES:
- Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer.
- Correlate changes in protein expression with expected changes based on planned therapy in these patients.
OUTLINE: This is a pilot, multicenter study.
Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT.
PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein expression analysis | Genetic | – |
Primary outcome
Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study
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 15 Mar 2012.
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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.
Steven K. Libutti, MD principal investigator
NCI - Surgery Branch
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study. It is what the study was designed to measure, not a finding.
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 15 Mar 2012.