Signal Detection in Monoclonal and New Agents in Lymphoma

NCT02849912 | Completed

• 1 other identifier: 12-PP-09
• Study Type: observational
• Target: 1,671
• Locations: 1 country
• Sites: 1

Brief Summary

Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) led for the first time to decline of the specific mortality. After treatment, patients with NHL experienced elevated risks for therapy-related leukemia, several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases which impact on quality of life. However little is known concerning long-term toxicity of this class of new agents so called "targeted drugs" such as anti-CD20. The primary objective of this cohort study is to estimate long term toxicity in NHL patients (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare drugs consumption to that of controls (i.e. external analysis).

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• Health problems

  Disproportionate reporting of health problems in relation with neuro-psychiatric troubles, cardio-vascular diseases, digestive tract diseases etc.

  Day 0

• health care use

  Disproportionate reporting of health care use (drug consumption, hospitalization, doctors consultations)

  Day 0

Interventions

questionnaire OTHER

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The database of patients in therapeutic trials LYSA, French group treated more than 10,000 patients over the last 20 years

You may qualify if:

• Initial diagnosis of histologically confirmed CD20+ diffuse large B-cell Lymphoma, De novo transformed follicular lymphoma (FL) is allowed
• Follicular lymphoma
• Mantle cell lymphoma
• Previously untreated with chemo- or radiotherapy
• Include in LYSA trial
• Age 18-90 years

You may not qualify if:

• Any other type of lymphoma.
• Previous treatment with chemotherapy or radiation therapy
• Contraindication to any drug contained in the chemotherapy regimen
• Previously known HIV positive serology
• Active hepatitis B or C
• Prior history of malignancies other than lymphoma within 3 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)