Regional Database for Collecting Clinical-biological and Imaging Data "Secondary Bone Oncology and Bone Localizations of Hematologic Diseases"

NCT05495802 | Not Yet Recruiting

• 2 other identifiers: 2019_592021-A00829-32
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Improving the effectiveness of cancer treatments makes it possible to lengthen patient survival. It is therefore important to ensure that the quality of life is also maintained by reducing pain and handicap. Some cancers tend to spread to the bone. The bone locations of cancer can weaken the bone and lead to complications such as fractures, pain, or compression of neurological structures. To avoid such complications, weekly multidisciplinary meetings (MM) bring together specialists (oncologists, rheumatologists, cancer surgeons, radiologists, radiotherapists, etc.) to discuss the files of patients with bone lesions from cancer. They offer specific treatments adapted to each patient to treat or reduce the risk of complications. The OOSLOH study aims to collect clinical, biological, and imaging data from patients for whom a discussion took place in bone dedicated MM. Based on these data, epidemiological studies could be carried out to better understand the clinical factors leading cancer to colonize bone. But also to determine the factors making it possible to prevent or better treat bone complications and improve the quality of life of patients. This study does not require any examinations or additional visits to the patient

Conditions

Bone Metastases

Keywords

bone localisations of haematological diseases; Cancer; bone metastasis; haematological diseases; quality of life; epidemiological data

Outcome Measures

Primary Outcomes (1)

• Percentage of alive patients

  through study completion, an average of 10 years

Secondary Outcomes (4)

• Percentage of patients without bone disease recurrence

  within one year after the multidisciplinary meeting

• Time to bone disease recurrence

  through study completion, an average of 10 years

• Number of bone recurrence Number of bone recurrence

  At each presentation of the patient file's to the MM,on average every week

• Epidemiological datas

  At the first presentation of patient's file to the MM, on average every week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients whose file is presented in MM OOSLOH for a diagnostic, therapeutic or follow-up question of a malignant bone lesion

You may qualify if:

• Patient aged 18 or over,
• Patient whose file is presented to the OOSLOH MM and who has not objected to the use of his non-nominative clinical, biological and imaging data
• Social insured patient

You may not qualify if:

• Patient who died before presentation to OOSLOH MM,
• Minor patient,
• Patient objecting to the use of their data for research purposes,
• Patient unable to express his right to object to his participation in the study.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Lille University Hospital Emergence Fund: collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marie-Hélène VIEILLARD, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Hélène VIELLARD, MD

CONTACT

0320445962; Marie-Helene.VIEILLARD@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: August 10, 2022

Record last verified: 2022-08