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Hyaluronic Acid

Blood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied.

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Kounosuke Watabe

This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.

PRIMARY OBJECTIVES:

I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease.

SECONDARY OBJECTIVES:

I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation \[CD\]24-/CD44+/epithelial specific antigen \[ESA\]+) cells will have the most aggressive growth in the bone, using an animal model.

OUTLINE:

Blood and bone marrow samples are collected and analyzed via flow cytometry and polymerase chain reaction (PCR). Cells are also transplanted into mice and studied.

Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer

Role of Hyaluronic Acid in Cancer Stem Cell Niche

Descriptive statistics will be generated. The relationship of each cell's bone metastatic ability and HAS2 expression will be examined using correlations within each group between these two measures. The mean values of the HAS2 expression and bone metastatic ability will be compared between groups using one-way analysis of variance (ANOVA) models. In addition, 2-sample t-tests will be used to compare the primary cancer and bone metastases groups.

Expression of CSC markers including CD24, CD44 and ESA will be examined. These will also be examined using descriptive statistics and compared with each other using one-way ANOVA models and 2-sample t-tests to compare the primary cancer and bone metastases groups.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Symptoms and General Pathology

Behaviors and Mental Disorders

Neoplasm Metastasis

Neoplastic Processes

Quality of Life

study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM

BOMET-QoL questionnaire

Study Director

Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).

Population: Patients over 18 with breast cancer and bone metastasis.

Inclusion criteria:

* Patient over 18 years of age.
* Patient diagnosed with breast cancer (BC) and bone metastases (BM).
* Patient who has granted informed consent in writing to participate in the study.
* Patient capable of understanding and completing the questionnaires.

Exclusion criteria:

* Patient with another type of disease that, in the investigator's opinion, could mask the study results.
* Patients with a life expectancy of less than 8 months.
* Patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis

Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis

Impact on the HRQoL of patients with BC and BM will be measured by the BOMET-QoL questionnaire in the context of normal clinical practice. The questionnaire will be administered to patients in each study visit from baseline visit to the final visit at 24 months. The score of the questionnaire will be measured as: Score: 0 - Always, 1 - Nearly always, 2 - Sometimes, 3 - Rarely, 4 - Never, were never is the best option and always means patient has a bad health condition.

Its cross-sectional validity will be evaluated by analysing the relationship between the BOMET-QoL scores and different clinical variables (presence of Skeleton-Related Event (SREs), symptoms and Eastern Cooperative Oncology Group (ECOG) index). The relationship between the pain VAS score and the question about state of health perceived by patient with HRQoL according to BOMET-QoL will be analysed.

BOMET-QoL will be considered rapidly completed if patients complete questionnaire in less than 10 minutes.

Sensitivity to change can be evaluated by calculating the effect size or the Minimum Clinically Important Difference, as statistics based on effect size provide direct information about the magnitude of the change, expressed as a variation, also used to calculate the Minimum Clinically Important Difference.

The impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores) will be measured by comparing patients who presented SREs with patients with without SREs.

ECOG: This scale consists of 5 levels (0 = No restrictions to carry out the activities normal, 1 = Restrictions to perform vigorous physical activities. It has the capacity to perform ambulation and light work, 2 = Ability to ambulate and perform personal care but not able to work. Capacity for standing and walking for\> 50% of waking hours, 3 = Able to perform care limited personal; Incarcerated or restrained to be in a chair for\> 50% of the hours of vigil, 4 = complete disability; he can not perform any personal care; it remains in bed or in a chair all the time, 5 = Death). In it the observer assesses the state of symptoms and the level of functioning in relation to ambulatory status and need for care. Patients with an Eastern Cooperative Oncology Group (ECOG) functional scale between 0-1 will obtain a higher score (better HRQoL) in the BOMET-QoL questionnaire.

At the baseline visit, patients who obtain higher scores on the Analogue Visual Pain Scale will obtain a lower score (worse HRQOL) in the BOMET-QoL questionnaire. Correlation between the BOMET-QoL scores and the pain VAS scores regarding whether it improves, stays the same or gets worse between the different study visits. VAS: 0 no pain - 10 unbearable pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer	NCT02331212	Breast Carcinom... Stage IV Breast...	Cytology Specim... Laboratory Biom...	20 Years - 60 Years	Wake Forest University Health Sciences
Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis	NCT03847220	Breast Carcinom...	BOMET-QoL quest...	18 Years -	Spanish Breast Cancer Research Group

Spots Global Cancer Trial Database for breast carcinoma metastatic to the bone