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L'essai clinique NCT04812912 pour Cancer colo-rectal, Néoplasmes colorectaux, Carcinome colorectal est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT04812912 est un essai observationnel pour Cancer colo-rectal, Néoplasmes colorectaux, Carcinome colorectal. Son statut actuel est : en recrutement. L'étude a débuté le 18 mars 2021 et vise à recruter 120 participants. Dirigé par le Centre de cancérologie Memorial Sloan Kettering, l'essai devrait être terminé d'ici le 18 mars 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 octobre 2025.
Résumé succinct
The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer. The study researchers will observe and track changes in hormone levels and in sexual and reproductive health in people with early onset colorectal cancer. This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).
Titre officiel

The Effects of Chemotherapy or Radiotherapy on Reproductive and Sexual Health of Early Onset Colorectal Cancer Patients

Conditions
Cancer colo-rectalNéoplasmes colorectauxCarcinome colorectal
Autres identifiants de l'essai
  • 21-035
Numéro NCT
NCT04812912
Date de début (réel)
2021-03-18
Dernière mise à jour publiée
2025-10-24
Date de fin (estimée)
2026-03-18
Inscription (estimée)
120
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
Early Onset Colorectal Cancer
Colorectal Cancer
21-035
Memorial Sloan Kettering Cancer Center
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Participants with Colon Cancer
This patient population will have hormone biomarker analysis, questionnaire (QOL) administration, and, if the patient is male, semen analysis
Hormone Biomarker Analysis
For female patients, hormone biomarker analysis will be performed to measure: anti-Mullerian hormone (AMH), estradiol and FSH in the blood. In male patients, hormone biomarkers of testicular function and spermatogenesis will be monitored: testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH. Sperm analysis will also be performed in male patients to monitor changes in sperm count.
Qol Questionnaires
All participants will respond to protocol questionnaires, which will include both validated questionnaires as well as non-validated ones. This design will allow for basic demographic, psychosocial and sexual-health-related data to be obtained.
Participants with Rectal Cancer
This patient population will have hormone biomarker analysis, QOL administration, and, if the patient is male, semen analysis
Hormone Biomarker Analysis
For female patients, hormone biomarker analysis will be performed to measure: anti-Mullerian hormone (AMH), estradiol and FSH in the blood. In male patients, hormone biomarkers of testicular function and spermatogenesis will be monitored: testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH. Sperm analysis will also be performed in male patients to monitor changes in sperm count.
Qol Questionnaires
All participants will respond to protocol questionnaires, which will include both validated questionnaires as well as non-validated ones. This design will allow for basic demographic, psychosocial and sexual-health-related data to be obtained.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Change in anti-Mullerian hormone (AMH), estradiol and FSH of oxaliplatin-induced gonadal toxicity in pre-menopausal female patients (<40y)
Up to 30 months
Change in testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH in young male patients (<50y) undergoing therapy for colorectal cancer
Up to 30 months
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
  • 18-40 years of age and premenopausal (female) or 18-50 years of age (male) at time of diagnosis
  • Histologic diagnosis of colorectal adenocarcinoma
  • Able and willing to participate in the informed consent process
  • Eligible for curative adjuvant or neoadjuvant therapy for colon or rectal cancer
  • Willing and able to complete protocol questionnaires
  • Rectal patients only: Individuals who will be receiving chemotherapy, followed by chemoradiotherapy (ChemoRT)

  • Prior systemic treatment for this malignancy
  • Active or prior secondary malignancy
  • History of ovarian resection (if female)
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test.
Memorial Sloan Kettering Cancer Center logoCentre de cancérologie Memorial Sloan Kettering737 essais cliniques actifs à explorer
Contact central de l'essai
Contact: Andrea Cercek, MD, 646-888-4189, [email protected]
Contact: Paul Romesser, MD, 646-888-2118, [email protected]
7 Centres de l'essai dans 1 pays

New Jersey

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement
Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement

New York

Memorial Sloan Kettering Cancer Center at Suffolk - Commack, Commack, New York, 11725, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement
Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement
Memorial Sloan Kettering Nassau, Rockville Centre, New York, 11553, United States
Andrea Cercek, MD, Contact, 646-888-4189
En recrutement