Neoplasms

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Participants undergoing osseous reconstructive surgery (RegOS) for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

Participants undergoing other reconstructive surgery for bone neoplasm. Study visits for post-op assessments will be annually after month-36.

Participant-reported outcome score. For lower extremities, this is a 33 item questionnaire containing 32 5 point Likert scale items and 1 open ended response item. For upper extremities, this is a 31 item questionnaire containing 31 5 point Likert scale items and 1 open ended response item. Individual item responses range from 1-5 with higher values indicating a task is easier to complete. A total questionnaire score can also be calculated by taking the sum of the scores minus the number of total items answered, and dividing this by the maximum possible score based on the number of items answered. This results in a range from 0 -100% with higher values indicating greater ability to complete tasks 31. This scoring allows for the fact that some items may not be answered if they do not apply to an individual. It is anticipated that it will take 20 minutes to complete. Scores for the lower extremity and upper extremity may be combined, but we intend to treat them separately for analysis.

Toronto Extremity Salvage Score

Clinician-reported global score. For lower extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, walking ability, gait, and necessary support. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. For upper extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, hand positioning, manual dexterity, and lifting ability. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. A total questionnaire score which is defined as the sum of the individual items divided by the maximum possible score (5 times the number of items) may also be computed. It is represented as a percentage from 0 - 100%.

Musculoskeletal Tumor Society Score

Validated functional measurement, for lower extremities only. The patient is observed and timed while s/he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. The test predicts the patient's ability to go outside alone safely and quantifies functional mobility. The test requires no special equipment and will take less than one minute to complete.

Timed Get Up and Go Test

The distance of bone transport is measured, accounting for calibration of the radiographs. The presence of bone regenerate between the transported segment is determined by the presence of continuous calcified callus from the proximal segment to the distal segment. Each of the orthogonal radiographs is used to visualize two cortices: the AP radiographs visualizes the medial and lateral cortices and the lateral radiograph measures the anterior and posterior cortices. Each continuous calcified cortex is counted with a range from 0 to 4 cortices intact.

Orthogonal Radiographs

As part of the current standard of care, patients are asked to stand on a scale with the affected lower extremity on the scale and the unaffected extremity on a block which is level with the scale. The patient is asked to place as much weight as possible on the affected extremity and this weight Is recorded. Each patient's total weight is then measured and the percent of weight bearing is calculated as the amount of weight bearing over the total body weight.

Weight Bearing for lower extremities only

As part of the current standard of care, the joints of the affected extremity are assessed for passive range of motion at each follow up visit by the clinician. If surgery is on the femur, the hip and knee joints are assessed for range of motion. Whereas for the tibia, the knee and ankle joints are assessed. These assessments would be measured using a goniometer placed alongside the extremity and recorded for each direction of movement. Hip range of motion includes flexion, extension, abduction, internal rotation and external rotation. Knee range of motion includes flexion and extension. Ankle range of motion includes dorsiflexion and plantarflexion.

Range of Motion

Daniel Prince, MD, MPH

John Healey, MD

Daniel Prince, MD

The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.

The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery

Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas

Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone

The primary objective is to assess early recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The early time frame is considered at one year from the neoplasm resection surgery.

The primary objective is to assess mid-recovery level of function of all participants undergoing reconstructive surgery after resection of osseous neoplasms. The mid-recovery time frame is considered at one year from the neoplasm resection surgery.

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Recurrence

Histiocytoma, Malignant Fibrous

Fibrosarcoma

Hemangiosarcoma

Leiomyosarcoma

Chondrosarcoma, Mesenchymal

Osteosarcoma, Juxtacortical

Histiocytoma

Neoplasms, Vascular Tissue

Neoplasms, Fibrous Tissue

Undifferentiated Pleomorphic Sarcoma

The Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry) is a non-interventional, multicentric, international, clinical and epidemiologic patient registry. The COSS-Registry collects key data on osteosarcomas or biologically related bone sarcomas. With that data collection we want to gain new scientific insights and results about this tumor disease, prognosis, surveillance and long-term effects.

Besides the data collection we would also like to foster the collection of biomaterial (tumor specimen and blood samples) for scientific research.

The stored material will be used to perform cell and molecular biological analyses to identify the causes of osteosarcoma, the prognosis and possible new treatment options.

As a starting point the donated biomaterial of registered patients will be analyzed firstly for the presence of a tumor predisposition by germline mutations.

In case of detected genetic variations that are related to the tumor disease and which may affect the patient's health and follow-up care (because of the potentially increased risk of developing other malignant tumors), affected patients will be informed and referred to genetic counseling.

Registry patients will be asked at the time of diagnosis if they wish to be informed about germline variants detected as part of the study procedures.

Osteosarcomas are rare and malignant bone tumors with an incidence of only 200-300 diagnoses in Germany each year. The biological behaviour of the tumor is not well understood yet. Treatment options and survival prognosis have not improved for the last decades.

The planned collection of treatment and follow-up data of affected patients at the COSS-Registry has the goal to gain further insights about this tumor, to improve survival rates and to identify possible germline variants in tumor predisposition genes in any patient diagnosed with OS.

It is also necessary to foster research on the genetic and molecular biological characteristics of osteosarcoma by analyzing biomaterial samples (especially tumor tissue) for example to identify new therapy targets or to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations.

Therefore a substantial amount of biomaterial has to be gathered and stored in a biobank. Accompanying to the COSS-Registry's data collection, biological samples taken from registered patients during routine measures and which are no longer required for further treatment will be stored in the COSS-Biobank.

The biological samples collected will be used to carry out genetic tests to check for an underlying tumor predisposition by germline mutations and for a next-generation sequencing of the whole genome. The goal of this project is to prospectively characterize the germline genetics in OS patients, to increase the understanding of the impact of germline alterations on the age of manifestation of OS, to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations and to integrate germline investigation and counselling into the routine workup of any child, adolescent or young adult diagnosed with OS registered at the COSS-Registry.

In this way, affected patients will benefit from their participation in the COSS-Registry and COSS-Biobank.

Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas

Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)

Aims of the registry are the collection of clinical data to gain further insights about diagnosis, treatment, prognosis and risk factors of osteosarcoma and biologically related bone tumors.

Aim of the registry is to give the frame for reference diagnostics.

Aim of the registry is the collection of biomaterial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas	NCT03442465	Bone Sarcoma Osteosarcoma Chondrosarcoma Ewing's Sarcoma Osseous Sarcoma Bone Neoplasm	Toronto Extremi... Musculoskeletal... Timed Get Up an... Orthogonal Radi... Weight Bearing ... Range of Motion	4 Years -	Memorial Sloan Kettering Cancer Center
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas	NCT05515068	Osteosarcoma Bone Tumor Bone Sarcoma High Grade Sarc... Osteoblastic Os... Chondroblastic ... Fibroblastic Os... Conventional Os... Conventional Ce... Low Grade Centr... Osseous Sarcoma Osseous Tumor Small Cell Oste... Telangiectatic ... Undifferentiate... Parosteal Osteo... Periosteal Oste... Extraskeletal O... Recurrent Osteo... High Grade Surf... Osseous Angiosa... Osseous Fibrosa... Osseous Leiomyo... Osseous Dediffe... Osseous Mesench... Clear Cell Oste...		-	Klinikum Stuttgart

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