- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07626814
Increasing Uptake of Cascade Testing in Families With Familial Cancer Syndromes: A Randomized Controlled Trial of a Registry-aided Model.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Singapore, Singapore, 168583
- National Cancer Centre, Singapore
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
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.
Andre navn:
|
|
Eksperimentell: 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.
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Uptake of cascade genetic testing.
Tidsramme: Up to 6 months after proband randomisation.
|
Proportion of at-risk FDRs who attend pre-test counselling and undergo cascade testing.
|
Up to 6 months after proband randomisation.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Barriers to cascade testing.
Tidsramme: Through study completion, estimated up to 6 months.
|
Qualitative themes from interviews with relatives who decline testing.
|
Through study completion, estimated up to 6 months.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Clin Asst Prof Chiang Jianbang, MBBS, MRCP (UK), MMed, National Cancer Centre, Singapore
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202104-00097
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .