NCT05512169 Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
| NCT ID | NCT05512169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Geneva, Switzerland |
| Condition | ALL, Childhood |
| Study Type | OBSERVATIONAL |
| Enrollment | 556 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 556 participants in total. It began in 2022-12-01 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva. The study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.
Eligibility Criteria
Inclusion Criteria: * Age \> 1 year old and ≤18 years old at enrolment * Previously untreated * ALL diagnosis confirmed by morphology and flow-cytometry * Indian origins * Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol * Written Informed consent to participate in the study has to be signed by the participant/parent/guardian Exclusion Criteria: * Previously tretaed patients * Patients with Down's syndrome * Patients with mature B-ALL
Contact & Investigator
Chakradhara Rao S UPPUGUNDURI
PRINCIPAL INVESTIGATOR
University of Geneva, Switzerland
Frequently Asked Questions
Who can join the NCT05512169 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying ALL, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05512169 currently recruiting?
Yes, NCT05512169 is actively recruiting participants. Contact the research team at chakradhara.uppugunduri@unige.ch for enrollment information.
Where is the NCT05512169 trial being conducted?
This trial is being conducted at New Delhi, India, Puducherry, India.
Who is sponsoring the NCT05512169 clinical trial?
NCT05512169 is sponsored by University of Geneva, Switzerland. The principal investigator is Chakradhara Rao S UPPUGUNDURI at University of Geneva, Switzerland. The trial plans to enroll 556 participants.