Cirkulerende tumorceller hos patienter med lokalt avanceret rektalcancer
Cirkulerende tumorelementer hos patienter med endetarmskræft
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.
Studieoversigt
Status
Betingelser
- Metastatisk rektal adenokarcinom
- Stadie III endetarmskræft AJCC v8
- Fase IIIA endetarmskræft AJCC v8
- Stadie IIIB endetarmskræft AJCC v8
- Stadie IIIC endetarmskræft AJCC v8
- Stadie IV endetarmskræft AJCC v8
- Stadie IVA endetarmskræft AJCC v8
- Stadie IVB endetarmskræft AJCC v8
- Stadie IVC endetarmskræft AJCC v8
- Lokalt avanceret rektalt adenocarcinom
- Tilbagevendende rektalt adenocarcinom
- Rectosigmoid Adenocarcinom
- Tilbagevendende rectosigmoid karcinom
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Healthy participants and patients diagnosed with rectal (or rectosigmoid) adenocarcinoma at MD Anderson Cancer Center.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
Tidsramme: 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
|
|
Change in circulating tumor cells status
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yi-Qian N You, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PA13-0547
- PA13-0547 (Anden identifikator: M D Anderson Cancer Center)
- NCI-2020-07460 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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