- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07626814
Increasing Uptake of Cascade Testing in Families With Familial Cancer Syndromes: A Randomized Controlled Trial of a Registry-aided Model.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Germline pathogenic/ likely pathogenic variants (PV/LPV) in cancer predisposition genes are defined as genetic alterations that increases an individual's susceptibility to cancer development. They are present in germ cells (egg or sperm) and can be passed down to subsequent generations.
Following the identification of a germline PV/LPV in a cancer predisposition gene in an index case presenting with disease (symptomatic proband), systematic cascade testing can be performed in relatives who have not yet developed disease (asymptomatic) to determine their future risk. Identifying asymptomatic carriers in families provides opportunities to ascertain hereditary risk, prevent disease via risk reduction surgery, diagnose disease in earlier stages, and ultimately improve clinical outcomes.
In spite of the evidence in support of cascade testing, there remain significant barriers to uptake that hinder the ability of a proband in Singapore to disseminate this critical information to his/her family.
The conventional approach to cascade testing in Singapore and most countries is to encourage probands with PV/LPV in cancer predisposition genes to relay this genetic information to their relatives and encourage them to see a genetic counsellor for discussion on predictive genetic testing. This proband-initiated disclosure is often suboptimal due to a myriad of reasons.
To improve the uptake rate of cascade testing in families at high risk of cancers, we propose a registry-aided outreach to family members of probands to bypass the barriers inherent with the proband-dependent approach. Our study shares the burden of communicating genetic results by having a healthcare professional reach out to family members and discuss the implications of germline cascade testing with at-risk relatives (ARRs). Alternative communication channels to reach out to relatives, independent of the proband, is thus created and propagated. This new model to enhance cascade testing features a two-pronged approach - personal communication by the proband, as well as a secondary registry-aided outreach to contact at-risk relatives.
This proposal is evaluated using a cluster randomized controlled trial to compare the effectiveness of the outreach program by comparing the cascade testing uptake rates between the current proband-dependent approach (control arm) and the combination of the proband-dependent approach with additional registry-aided testing reminders (experimental arm).
An in-depth interview with relatives who declined cascade testing will also be conducted to elucidate other barriers to cascade testing in the local population.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 168583
- National Cancer Centre, Singapore
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Probands:
- Patients who undergo clinical genetic testing and seen at the Cancer Genetics Service (CGS) in National Cancer Centre Singapore
- Pathogenic variant/ likely pathogenic variant (PV/LPV) identified in a cancer predisposition gene
- Aged 21 years old and over
- Singapore citizen or permanent resident
ARRs:
- ARRs of a proband
- Aged 21 years old and over
- Singapore citizen or permanent resident
Exclusion Criteria:
- Lacks capacity to consent
- Not living in Singapore
- Probands who decline to share relatives' contact details
- Probands with no contactable relatives in Singapore
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Control arm: Proband-dependent approach
The conventional approach to cascade testing whereby probands are advised to relay their genetic information to relatives and encourage them to see a genetic counsellor for discussion on predictive genetic testing.
Family letters are given to probands to help disseminate this information.
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Probands assigned to the control arm will be offered family letters to distribute to their at-risk relatives (ARRs).
These family letters encourage relatives to see a general practitioner for a referral to genetic counselling and cascade testing.
Otros nombres:
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Experimental: Proband-dependent with registry-reminders approach
A registry-aided outreach to family members of probands to bypass the barriers inherent with the proband-dependent approach.
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Otro: Combination of the proband-dependent approach with additional registry-aided testing reminders
Like the control arm, probands will be given the same family letters to distribute to their ARRs. In addition, a genetics coordinator will contact their first-degree relatives (FDRs) by phone/ email to inform them about genetic testing and advise them to obtain a referral from a general practitioner. The coordinator will remind relatives of their eligibility for genetic testing and assist them with queries at 1, 3, and 6 months after initial contact. Upon visiting for pre-test genetic counselling, FDRs will be further invited to provide contact details of other untested. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Uptake of cascade genetic testing.
Periodo de tiempo: Up to 6 months after proband randomisation.
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Proportion of at-risk FDRs who attend pre-test counselling and undergo cascade testing.
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Up to 6 months after proband randomisation.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Barriers to cascade testing.
Periodo de tiempo: Through study completion, estimated up to 6 months.
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Qualitative themes from interviews with relatives who decline testing.
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Through study completion, estimated up to 6 months.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clin Asst Prof Chiang Jianbang, MBBS, MRCP (UK), MMed, National Cancer Centre, Singapore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202104-00097
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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