Cellule tumorali circolanti in pazienti con cancro del retto localmente avanzato
Elementi tumorali circolanti in pazienti con cancro del retto
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.
Panoramica dello studio
Stato
Condizioni
- Adenocarcinoma rettale metastatico
- Cancro del retto in stadio III AJCC v8
- Cancro del retto in stadio IIIA AJCC v8
- Cancro del retto in stadio IIIB AJCC v8
- Cancro del retto in stadio IIIC AJCC v8
- Cancro del retto in stadio IV AJCC v8
- Cancro del retto in stadio IVA AJCC v8
- Cancro del retto in stadio IVB AJCC v8
- Cancro del retto in stadio IVC AJCC v8
- Adenocarcinoma rettale localmente avanzato
- Adenocarcinoma rettale ricorrente
- Adenocarcinoma rettosigmoideo
- Carcinoma rettosigmoideo ricorrente
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- M D Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yi-Qian N You, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PA13-0547
- PA13-0547 (Altro identificatore: M D Anderson Cancer Center)
- NCI-2020-07460 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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