Breast CancerNCT00204880
Aging and Cancer Effects (ACE) Study
An observational study of Breast Cancer and Lung Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Hypotheses: 1. Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains. 2. Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer. 3. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women over the age of 55 newly diagnosed with lung, breast, colon or rectal cancer, and with an anticipated life expectancy of at least 2 years for breast cancer patients,1 year for patients with lung cancer, and 2 years for patients with colon or rectal cancer. There is no upper age limit for participation in this study.
Who may be able to join
- Willing to do memory testing
- Willing to participate in activities of daily living assessment
- Can use a cane or walker
- Willing to complete a balance performance assessment, if able.
Who cannot join
- Currently receiving treatment for cancer.
- Has a previous history of brain cancer
- Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aging and Cancer: The Effects of Comorbidities on Cancer and it's Treatment
Hypotheses:
- Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains.
- Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer.
- Some aspect of baseline patient characteristic will be predictive of cancer-related outcomes.
- Conditions
- Breast Cancer, Lung Cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2009
- Study completionDec 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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Asthana, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204880
- Sponsor's protocol ID
- 2004-0341
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Cancer: The Effects of Comorbidities on Cancer and it's Treatment
- ClinicalTrials.gov ID
- NCT00204880
- Acronym / sponsor ID
- 2004-0341
- Conditions
- Breast Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (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.
Hypotheses:
- Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains.
- Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer.
- Some aspect of baseline patient characteristic will be predictive of cancer-related outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over the age of 55 newly diagnosed with lung, breast, colon or rectal cancer, and with an anticipated life expectancy of at least 2 years for breast cancer patients,1 year for patients with lung cancer, and 2 years for patients with colon or rectal cancer. There is no upper age limit for participation in this study.
Key inclusion criteria (4 listed)
- Willing to do memory testing
- Willing to participate in activities of daily living assessment
- Can use a cane or walker
- Willing to complete a balance performance assessment, if able.
Key exclusion criteria (3 listed)
- Currently receiving treatment for cancer.
- Has a previous history of brain cancer
- Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury.
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 5 Oct 2015.
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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.
Sanjay Asthana, MD principal investigator
University of Wisconsin, Madison
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 Lung Cancer, run by University of Wisconsin, Madison 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 4 inclusion and 3 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 5 Oct 2015. 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 5 Oct 2015.