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Gender Differences in Pediatric Hematopoietic Stem Cell Transplantation (HSCT)

I

IRCCS Burlo Garofolo

Status

Completed

Conditions

Hematopoietic Stem Cell Transplantation

Treatments

Procedure: Hematopoietic stem cell transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT04580576
RC 25/2019

Details and patient eligibility

About

Gender medicine considers the way in which gender, male or female, affects the development and impact of diseases and the response to therapies. It can be said that it is a new transversal dimension of medicine, which evaluates the gender differences in the physiology, pathophysiology and clinic of many diseases and thus sets itself the goal of reaching optimal therapeutic decisions both in men and women based on proven scientific evidence.

Although knowledge of gender medicine has increased significantly in recent years, a gender approach has not been much developed in pediatrics. In the field of bone marrow transplants, hematopoietic stem cell transplantation is known to be the most effective consolidation therapy in some high-risk hematology malignancies such as acute lymphoblastic leukemia and acute myeloid leukemia, and represents one of the potential treatment for patients suffering from solid tumors and genetic hematological, metabolic diseases and primary immunodeficiencies. Huge progress has been made in high resolution donor typing, choice of conditioning regimens, manipulation of hematopoietic stem cells (HSC) and prevention of serious infections in recent years, which have significantly improved the survival rate of patients undergoing to this procedure.

International literature regarding the response and outcomes from hematopoietic cell transplantation in a gender perspective is completely absent, for these reasons this pilot study was born from the need to understand from a broader perspective and in order to better understand how the gender may or not influence the outcome of transplantation in pediatric patients.

This retrospective analysis of the data will concern all patients who underwent allogeneic or autologous bone marrow transplant. The data will be collected from clinical records and from Regional electronic databases. All data will be collected anonymously and an identification code will be assigned to each case.

Enrollment

200 patients

Sex

All

Ages

4 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  1. Patients aged between 4 months and 17 years
  2. Diagnosis of oncohaematological disease subjected to hematopoietic stem cell transplantation
  3. Allogeneic or autologous bone marrow transplantation from January 2000 to October 2018
  4. Consent acquired for the processing of data for research purposes

Trial design

200 participants in 2 patient groups

Female group
Description:
Pediatric female patients undergoing hematopoietic stem cell transplantation
Treatment:
Procedure: Hematopoietic stem cell transplantation
Male group
Description:
Pediatric male patients undergoing hematopoietic stem cell transplantation
Treatment:
Procedure: Hematopoietic stem cell transplantation

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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