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NCT Number: NCT05237063

Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach

Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.

The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Nord

Amiens, 80054, France

Location status: Recruiting

Location contact

Amélie Bonnefond, DR

PRINCIPAL_INVESTIGATOR

Dominique Eladari, Pr

CONTACT

[email protected]

06 13 03 99 01

Isabelle Fournier, Dr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years old), male or female ,
  • Persons able to understand and object to the information provided (at the discretion of the investigator)
  • Patient affiliated to social security
  • Patient agreeing to sign the informed consent form
  • patient having presented at least one renal colic attack before inclusion

Exclusion criteria

  • Pregnant or breastfeeding woman.
  • Persons deprived of liberty,
  • Adults under legal protection guardianship, or curators or unable to express their consent.
  • Patient refusing to participate in the study
  • Patient in an emergency situation

Treatment and study plan

Blood and urine samples

Biological

Additional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits

Primary outcomes

  1. Number of patients with nephrolithiasis recurrence within 5 years of follow-up

    Time frame: at 5 years

Secondary outcomes

  1. Occurrence of high blood pressure patients

    Time frame: at 1 year

  2. Occurrence of high blood pressure patients

    Time frame: at 3 years

  3. Occurrence of high blood pressure patients

    Time frame: at 5 years

  4. Occurrence of patients with diabetes

    Time frame: at 1 year

  5. Occurrence of patients with diabetes

    Time frame: at 3 year

  6. Occurrence of patients with diabetes

    Time frame: at 5 year

  7. Occurrence of patients with osteopenia

    Time frame: at 1 year

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  8. Occurrence of patients with osteopenia

    Time frame: at 3 year

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  9. Occurrence of patients with osteopenia

    Time frame: at 5 year

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  10. Occurrence of patients with a deterioration in renal function

    Time frame: at 1 year

    Occurrence of patients with a deterioration in renal function during follow-up

  11. Occurrence of patients with a deterioration in renal function

    Time frame: at 3 year

    Occurrence of patients with a deterioration in renal function during follow-up

  12. Occurrence of patients with a deterioration in renal function

    Time frame: at 5 year

    Occurrence of patients with a deterioration in renal function during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Eladari, Pr

CONTACT

[email protected]

06 13 03 99 01

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Institut Pasteur de Lille
  • Université de Lille

Registry information

Acronym: PRECILITH

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Feb 11, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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