Breast CancerNCT00898781
Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer
An observational study of Breast Cancer and Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread. PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Ovarian Cancer
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Registration - Inclusion Criteria * Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease or pre-operative clinically staged 3 ovarian cancer or locally advanced or metastatic pancreatic cancer. * Not received prior therapy for metastatic disease. Registration - Exclusion Criteria: -History of any prior cancer
DISEASE CHARACTERISTICS:
- Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No history of any prior cancer
PRIOR CONCURRENT THERAPY:
- No prior therapy for metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Detection of Circulating Cancer Cells in Breast, Ovarian, Colon and Pancreatic Cancer
RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.
PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.
Read the detailed description
OBJECTIVES:
- To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
- To assess the variability in number of CTCs between patients with the same tumor type.
- To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.
OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer
- Keywords
- male breast cancer, stage IV breast cancer, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, stage IV pancreatic cancer, stage IV colon cancer, ovarian sarcoma
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Male, Carcinoma, Ovarian Epithelial, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer | Not described | |
| Metastatic Ovarian Cancer | Not described | |
| Metastatic Pancreatic Cancer | Not described | |
| Metastatic Colon Cancer | Not described | |
| Stage 3 Ovarian Cancer | Not described | |
| Locally Advanced Pancreatic Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of circulating cancer cells (CTC)
Measured: 1 day
Variability in number of CTCs between patients with the same tumor type
Measured: 1 day
Correlation of the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers
Measured: 1 day
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 startNov 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Due to poor accrual
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 Mayo ClinicThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Charles Erlichman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898781
- Sponsor's protocol ID
- CDR0000582085
- Other IDs
- P30CA015083, MC0744, 07-006779
- Status last verified
- Jul 2011
- First submitted
- 9 May 2009
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Detection of Circulating Cancer Cells in Breast, Ovarian, Colon and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00898781
- Acronym / sponsor ID
- CDR0000582085
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer
- Keywords
- male breast cancer, stage IV breast cancer, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, stage IV pancreatic cancer, stage IV colon cancer, ovarian sarcoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to poor accrual
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (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: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.
PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.
Detailed description
OBJECTIVES:
- To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
- To assess the variability in number of CTCs between patients with the same tumor type.
- To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.
OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer | – | – |
| Metastatic Ovarian Cancer | – | – |
| Metastatic Pancreatic Cancer | – | – |
| Metastatic Colon Cancer | – | – |
| Stage 3 Ovarian Cancer | – | – |
| Locally Advanced Pancreatic Cancer | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registration - Inclusion Criteria * Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease or pre-operative clinically staged 3 ovarian cancer or locally advanced or metastatic pancreatic cancer. * Not received prior therapy for metastatic disease. Registration - Exclusion Criteria: -History of any prior cancer
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
Frequency of circulating cancer cells (CTC)
Time frame: 1 day
Variability in number of CTCs between patients with the same tumor type
Time frame: 1 day
Correlation of the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
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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.
Charles Erlichman, MD principal investigator
Mayo Clinic
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 Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2011. 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 (reason given: Due to poor accrual). 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?
Frequency of circulating cancer cells (CTC) (time frame: 1 day). The study lists 3 primary outcomes in all. 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 19 Jul 2011.