Breast CancerNCT00900068
Blood Samples From Patients on a Clinical Trial to CINV During HSCT
An observational study of Breast Cancer and Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment. PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor
- What is being tested?
- immunoenzyme technique, laboratory biomarker analysis and medical chart review
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During the pilot study, serum samples were collected from a subgroup of patients in both the placebo and the aprepitant arms
DISEASE CHARACTERISTICS:
- Previously collected serum samples from patients with cancer enrolled on the placebo arm of the pilot aprepitant study
- Patients treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: Substance P Follow-up to a Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplantation
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.
PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
- To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.
OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.
Patients' medical records are reviewed for demographic information, past history, and course of treatment.
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- immunoenzyme technique, laboratory biomarker analysis, medical chart review
- Keywords
- nausea and vomiting, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma
- Medical subject headings
- Breast Neoplasms, Myeloproliferative Disorders, Gestational Trophoblastic Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoenzyme techniqueOther
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Average, median, and mode for substance P levels at different times
Secondary outcomes (1)
Correlation of substance P levels with patient response (emesis or not)
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 startAug 2008
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, BCPS, BCOP, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900068
- Sponsor's protocol ID
- CDR0000617385
- Other IDs
- P30CA069533, OHSU-CPC-08055-L, OHSU-IRB 4517, MERCK-OHSU-CPC-08055-L
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 9 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance P Follow-up to a Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT00900068
- Acronym / sponsor ID
- CDR0000617385
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- nausea and vomiting, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (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 blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.
PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
- To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.
OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.
Patients' medical records are reviewed for demographic information, past history, and course of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During the pilot study, serum samples were collected from a subgroup of patients in both the placebo and the aprepitant arms
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 |
|---|---|---|
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Average, median, and mode for substance P levels at different times
1 secondary outcome
Correlation of substance P levels with patient response (emesis or not)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Joseph Bubalo, PharmD, BCPS, BCOP principal investigator
OHSU Knight Cancer Institute
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 Breast Cancer and Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute 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?
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: stopped early, as of the sponsor's last update on 9 May 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 was stopped early. Results are not available in the source record.
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?
Average, median, and mode for substance P levels at different times. 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 9 May 2017.