Cellules tumorales circulantes chez les patients atteints d'un cancer rectal localement avancé
Éléments tumoraux circulants chez les patients atteints d'un cancer du rectum
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.
Aperçu de l'étude
Statut
Les conditions
- Adénocarcinome rectal métastatique
- Cancer rectal de stade III AJCC v8
- Cancer du rectum de stade IIIA AJCC v8
- Cancer du rectum de stade IIIB AJCC v8
- Cancer du rectum de stade IIIC AJCC v8
- Cancer rectal de stade IV AJCC v8
- Cancer rectal de stade IVA AJCC v8
- Cancer rectal de stade IVB AJCC v8
- Cancer rectal de stade IVC AJCC v8
- Adénocarcinome rectal localement avancé
- Adénocarcinome rectal récurrent
- Adénocarcinome rectosigmoïde
- Carcinome rectosigmoïde récurrent
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.
II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.
III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.
OUTLINE:
Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- M D Anderson Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.
La description
Inclusion Criteria:
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HEALTHY SUBJECT: No known diagnosis of colorectal cancer (CRC) or any other type of cancer for the last 10 years.(basal cell skin cancer is allowed). Subjects will be asked about their cancer history and a verbal confirmation is required
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Any patient with diagnosis of rectal (or rectosigmoid) adenocarcinoma, including:
- Patients with primary disease with or without neoadjuvant therapy; OR
- Patients with recurrent disease with or without neoadjuvant therapy; OR
- Patients with metastatic disease with or without prior treatment
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No known current diagnosis of other invasive cancer; if prior diagnosis of other cancer, he/she has been free from cancer for >= 3 years and is on no active treatment
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Adequate mental and language capacity to provide consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Ancillary-Correlative (biospecimen collection)
Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back. |
Undergo collection of blood sample |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
Délai: Baseline up to 6 years
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The proportion of patients with any CTC will be calculated with a 95% confidence interval (CI). Additionally, the actual CTC count will be plotted with a box-plot. Proportions of patients with 2 or more, and 3 or more CTCs will be calculated. Will also explore correlations between the presence of 1 or more CTC and primary tumor characteristics using Chi-Squared or Fischer's exact tests as appropriate. |
Baseline up to 6 years
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|
Change in circulating tumor cells status
Délai: Baseline and 8 weeks after completion of treatment
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A McNemar's test will be used to test whether neoadjuvant therapy (NEO) provided any improvement in the proportion of patients with any CTC. The CTC counts at baseline versus 8 weeks after completion of treatment will be compared with a paired t-test. |
Baseline and 8 weeks after completion of treatment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yi-Qian N You, M.D. Anderson Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PA13-0547
- PA13-0547 (Autre identifiant: M D Anderson Cancer Center)
- NCI-2020-07460 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
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