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Immunoglobulins

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA testing

A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid testing

Julie Bottero, MD

With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.

Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

Subjects who are considered required to seek further care are as follows:

* those who need HBV vaccination (non-immunized)
* those who are infected with hepatitis B virus (infected)

Of these patients, subjects who have achieved appropriate care are considered as follows:

* non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
* infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)

The percentage of patients appropriately seeking care will be then calculated by the following formula:

((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))\*100

ANRS, Emerging Infectious Diseases

Gilead Sciences

Roche Pharma AG

Mairie de Paris

BioMérieux

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Any event possibly related to physical HBV test.

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA Testing

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid Testing

Total

Age, Continuous

Sex: Female, Male

Low (<2.0%)

Intermediate (2.0-8.0%)

High (>8.0%)

HBV prevalence of birth country

Social security

Health insurance plan

All participants completing their intervention.

Low prevalence of HBV infection; individuals with barriers to healthcare were underrepresented; Quick Profile anti-HBsAb rapid test unable to confirm nonimmunized status; intervention had same-day blood draws, which is not done in routine practice.

Dr. Julie Bottero

Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.

Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).

Percentage of Patients Appropriately Seeking Care

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Financial Stress

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.

Cancer care is transitioned to a satellite site.

Care transition

Cancer care is not transitioned to a satellite site.

No care transition

Mark Fiala, Ph.D. MSW

Mark Fiala, Ph.D., MSW

There is very limited data on the utilization of National Cancer Institute Comprehensive Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards to providing chemotherapy at facilities closer to patients' home. These "satellite chemotherapy infusion centers", typically community-based treatment locations at community hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by patients who utilize their services and reduce their travel times and expenses. In these studies patients still remained in the care of their current provider and site and are required to travel to the site for clinical visits and other appointments. It is currently unknown if patients are willing to transfer their care to a different provider to alleviate travel burden. In addition, although increased travel burden has been lower quality of life in cross-sectional studies, no data exists suggesting that these reducing travel burden can improve these outcomes intra-patient, to the knowledge of the investigators.

The patient roles of the multiple myeloma clinical providers at the Siteman primary location have grown in recent years. The providers have determined a need to refer some patients to the satellite sites to relieve congestion at the site while also hopefully improving the clinical experience for those patients. This study is a natural experiment of this process.

Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

* Explore differences in participant experience between those that elect to transfer to a satellite site and those who decline to transfer.
* The Modified Treatment Burden Questionnaire will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 3 questions with answers ranging from 0 (not a problem) to 10 (big problem). The higher the score the more treatment burden the participant experienced.

* Explore differences in participant satisfaction between those that elect to transfer to a satellite site and those who decline to transfer.
* The Questionnaire on the Quality of Physician-Patient Interaction will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 14 questions with answers ranging from 1 (do not agree) to 5 (I fully agree). The higher the score the higher the quality of the physician-patient interactions.

* Explore differences in participant financial toxicity between those that elect to transfer to a satellite site and those who decline to transfer.
* The Comprehensive Score for Financial Toxicity will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 11 questions with answers ranging from 0 (not at all) to 4 (very much). The higher the score the less financial toxicity the participant experienced.

A sample of 20 patients, approximately 10 who decided to transfer and 10 who declined, will be surveyed in regards to the reason(s) for their decision as part of a sub-study. Patients who were not enrolled in the prospective portion of the study, either due to declining or not approached, will be allowed to enroll in the sub-study as long as they were offered the ability to transfer to a satellite site by their provider.

Washington University School of Medicine

The growing incidence of cancer associated to an aging population represents an epidemiologic reality that requires questioning access to care and prognosis in elderly with cancer, for which disparities have been highlighted. However, generally speaking, studies are limited in that they overlook geriatric-specific factors. The aim of this work was to study sociodemographic, socioeconomic and clinical determinants of access to care (cancer stage, cancer treatment) and prognosis (functional decline, survival) in elderly cancer patients.

The French department of Gironde (1.5 million inhabitants) is covered by cancer registries. In addition, three cohorts were initiated in Gironde on cerebral and functional aging that enrolled subjects aged 65 years and over: the PAQUID study (1988), the 3-City study (1999), and the AMI study (2007). In these cohorts, a large amount of individual data on the participants has been collected longitudinally at different follow-up visits, conducted every two or three years.

Using cancer registries, older subjects with cancer were identified in the cohort studies. Subjects were included if they presented the following: i) aged 65 years and over from one of the three cohorts, ii) alive on January 1st 2005 (common start date for tumor recording) and resident in Gironde, and iii) with a validated cancer diagnosis recorded in one of the cancer registries from January 1st 2005 to December 31st 2014. All tumors for which data is annually sent by cancer registries to the International Agency for Research of Cancer were included: invasive malignant tumors and benign tumors of the central nervous system. As the incidence of skin tumors in older cancer patients is high, they were also included. For patients with multiple tumors, only one was considered: either the first one diagnosed if there were several tumors with a minimum of a 6 months interval between their diagnosis, or the one with the worse prognosis if there were several tumors diagnosed within 6 months.

In order to not consider information concerning patients' characteristics that was too old, subjects with a delay between the last completed cohort follow-up visit before the cancer diagnosis and the diagnosis of cancer equal or superior to 6 years were excluded.

Variables were extracted from cohorts and registries at different times: cohort inclusion, pre-diagnosis visit, cancer diagnosis or registries follow-up.

Access to Care and Prognosis in Elderly With Cancer (INCAPAC Study)

Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department

Advanced stage at diagnosis measured from cancer registries data

Receipt of cancer treatment (all treatment considered) from cancer registries data

Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Instrumental Activities of Daily Living (IADL) scale

Change in functional status between cancer pre-diagnosis assessment and cancer post-diagnosis assessment measured with Activities of Daily Living (ADL) scale

Time from cancer diagnosis to death or last follow-up, whichever came first

Institut National de la Santé Et de la Recherche Médicale, France

University of Bordeaux

Institut Bergonié

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Immunomodulating Agents

Immunologic Factors

Chemotherapy

Immunotherapeutic Agent

target treatment

Surgery

Radiotherapy

Maud Toulmonde, MD

Simone Mathoulin-Pélissier, MD/PhD

Antoine Italiano, MD/PhD

Jean-Yves Blay, MD/PhD

Axel Le Cesne, MD/PhD

The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas \[RESOS\] / French expert network dedicated to the pathology of sarcomas \[RREPS\]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas \[NETSARC\]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.

Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.

With the financial support of the French National Cancer Institute \[Institut National du cancer \[INCa\]).

National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group

The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas

Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.

Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma	NCT05971056	Multiple Myelom...	Care transition No care transit...	18 Years -	Washington University School of Medicine
Access to Care and Prognosis in Elderly With Cancer (INCAPAC Study)	NCT03694171	Cancer		65 Years - 110 Years	Institut Bergonié
National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group	NCT03978039	Sarcoma	Chemotherapy Immunotherapeut... target treatmen... Surgery Radiotherapy	-	Institut Bergonié
National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group	NCT03978039	Sarcoma	Chemotherapy Immunotherapeut... target treatmen... Surgery Radiotherapy	-	Institut Bergonié
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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