Anatomic Stage I Breast Cancer AJCC v8NCT04876378
Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 24 May 2022
- 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 Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a diagnosis of breast cancer and normal controls.
Who may be able to join
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
- Breast cancer patients with either natural or chemically induced menopause with stage 1-3 hormone receptor-positive breast cancers and on AI for at least one year OR healthy postmenopausal women
- Breast cancer patients on aromatase inhibitors (AI) may fall into one of the three following groups:
- Patients with knee pain with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) >= 5, but no or minimal hand/wrist pain
- Patients with self-reported moderate or severe hand/wrist pain but no or only mild knee pain (WOMAC =< 7)
- Patients with no or minimal hand/wrist or knee pain (WOMAC =< 7)
- Age <= 70 years old
- Ability to read and complete quality of life surveys in English (or have a family member or friend available to translate and assist in completing surveys)
Who cannot join
- History of prior traumatic injury at knee joint or severe degenerative joint disease or osteoarthritis defined as having a history of prior joint replacement or moderate to severe knee pain prior to initiation of AI
- History of claustrophobia
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data, including prior history of implanted devices with ferromagnetic objects
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To investigate pathological alterations in cartilage and joints in breast cancer patients on aromatase inhibitor (AI)s with and without pain and in healthy control patients.
OUTLINE:
Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI of about 60 minutes.
After completion of study, a subset of patients are followed up at 6 months.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Magnetic Resonance Imaging, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (questionnaires, MRI) | Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI over 60 minutes. Receives: Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean differences in hyaline cartilage biochemical composition
Will determine differences in hyaline cartilage biochemical composition (using magnetic resonance imaging) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).
Measured: Up to 6 months
Differences in morphological joint abnormalities
Will determine differences in morphological joint abnormalities (using semi-quantitative magnetic resonance-based scores) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start18 May 2020
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Krug, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876378
- Sponsor's protocol ID
- 20923
- Other IDs
- NCI-2020-03535
- Status last verified
- Sep 2022
- First submitted
- 5 May 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
- ClinicalTrials.gov ID
- NCT04876378
- Acronym / sponsor ID
- 20923
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 6 May 2021 (actual)
- 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.
This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.
Detailed description
PRIMARY OBJECTIVE:
- To investigate pathological alterations in cartilage and joints in breast cancer patients on aromatase inhibitor (AI)s with and without pain and in healthy control patients.
OUTLINE:
Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI of about 60 minutes.
After completion of study, a subset of patients are followed up at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (questionnaires, MRI) | – | Procedure: Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI over 60 minutes. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of breast cancer and normal controls.
Key inclusion criteria (8 listed)
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
- Breast cancer patients with either natural or chemically induced menopause with stage 1-3 hormone receptor-positive breast cancers and on AI for at least one year OR healthy postmenopausal women
- Breast cancer patients on aromatase inhibitors (AI) may fall into one of the three following groups:
- Age <= 70 years old
- Ability to read and complete quality of life surveys in English (or have a family member or friend available to translate and assist in completing surveys)
Key exclusion criteria (3 listed)
- History of prior traumatic injury at knee joint or severe degenerative joint disease or osteoarthritis defined as having a history of prior joint replacement or moderate to severe knee pain prior to initiation of AI
- History of claustrophobia
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data, including prior history of implanted devices with ferromagnetic objects
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Diagnostic (questionnaires, MRI) |
| Questionnaire AdministrationComplete questionnaires | Other | Diagnostic (questionnaires, MRI) |
Primary outcome
Mean differences in hyaline cartilage biochemical composition
Time frame: Up to 6 months
Will determine differences in hyaline cartilage biochemical composition (using magnetic resonance imaging) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).
Differences in morphological joint abnormalities
Time frame: Up to 6 months
Will determine differences in morphological joint abnormalities (using semi-quantitative magnetic resonance-based scores) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Roland Krug, PhD principal investigator
University of California, San Francisco
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 Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of California, San Francisco 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 8 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: stopped early, as of the sponsor's last update on 9 Sep 2022. 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: Funding). 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?
Mean differences in hyaline cartilage biochemical composition (time frame: Up to 6 months). The study lists 2 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 9 Sep 2022.