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Bone Metastases clinical trials

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NCT ID: NCT03908853 Recruiting - Pain Clinical Trials

Pain Phenotyping of Patients With Bone Cancer Pain

BonemetPAIN
Start date: February 5, 2019
Phase:
Study type: Observational

The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.

NCT ID: NCT03823534 Recruiting - Pain Clinical Trials

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Start date: February 20, 2019
Phase: Phase 3
Study type: Interventional

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

NCT ID: NCT03814811 Recruiting - Breast Neoplasms Clinical Trials

Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis

COP-BREAST
Start date: July 1, 2017
Phase:
Study type: Observational

Bone metastasis (i.e. cancer cell spreading to bone) is the major clinical problem of advanced breast cancer patients. Bone metastasis is not curable nor preventable. Currently available therapeutic approaches are only palliative. The major hurdle for improving bone metastasis treatment is lack of sensitive diagnostic tools. Diagnosis of bone metastasis is heavily dependent on radiographic imaging of bone destruction that are detectable only when the lesion is significantly large. Accordingly, if bone metastasis can be detected at an earlier time point when bone destruction is minimal or incipient, treatments can be given earlier and the patients can expect better outcomes. We and others previously have found that a subset of bone-forming cells (i.e. circulating osteocalcin-positive cells) exists in the blood stream of the patients with bone diseases (e.g. bone metastasis and inflammation) or active bone formation (e.g. adolescence) in mouse models anf human samples. Extended from this laboratory observation, this clinical study proposes to test the hypothesis that circulating osteocalcin-positive cells are the early biomarker of breast cancer bone metastasis. For this aim, this study will measure circulating osteocalcin-positive cells in the blood samples of breast cancer patient, and examine whether the measure sensitively detects bone metastasis.

NCT ID: NCT03550508 Recruiting - Bone Metastases Clinical Trials

Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors

JMT103
Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL. In preclinical studies, JMT103 demonstrated strong activity through blocking RANKL receptor, RANK on the surface of osteoclasts, leading to inhibit osteoclast differentiation, activation, and maturation and reduce bone resorption. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) ,to evaluate the safety, pharmacokinetics and preliminary efficacy (bone turnover markers) of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) in patients with bone metastases from tumors at single doses and multiple doses. About 36 cases patients are to be recruited.

NCT ID: NCT03503682 Recruiting - Palliative Care Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

NCT ID: NCT03377517 Recruiting - Bone Metastases Clinical Trials

Radiosurgical Hypophysectomy for Bone Metasteses Pain

Start date: May 8, 2018
Phase: N/A
Study type: Interventional

This research is being done to see if a delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.

NCT ID: NCT03336983 Recruiting - Prostate Cancer Clinical Trials

Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients

BonEnza
Start date: December 1, 2017
Phase: Phase 2
Study type: Interventional

This study was undertaken to evaluate bone response in metastatic prostate cancer patients treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing hormone-releasing hormone (LHRH) analogue with the use of Whole Boby (WB) DW-MRI.

NCT ID: NCT03261544 Recruiting - Sarcoma Clinical Trials

Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

Start date: November 10, 2017
Phase:
Study type: Observational

The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.

NCT ID: NCT03143322 Recruiting - Clinical trials for Metastatic Breast Cancer

Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

STEREO-OS
Start date: January 24, 2018
Phase: N/A
Study type: Interventional

Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis). The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies. Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy. The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers). Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy. In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 5 metastases) in solid tumor patients is able to improve the survival without progression.

NCT ID: NCT02810262 Recruiting - Lung Cancer Clinical Trials

Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

POUMOS
Start date: June 2011
Phase:
Study type: Observational

Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival. Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers. Survival analyses will be performed using a proportional hazard regression model.