NCT02812680

Brief Summary

Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized to be associated with response to chemoradiation in patients undergoing treatment for locally advanced esophageal adenocarcinoma. The goal of this project is to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

4.4 years

First QC Date

June 14, 2016

Last Update Submit

March 7, 2024

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Circulating microRNA (miRNA) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using Human miRNA cards

    2 years

  • Circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy by using CTC chips

    2 years

Study Arms (2)

Esophageal Cancer Patients - Blood Draw

Look at blood samples to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy in patients with Esophageal Adenocarcinoma.

Other: Blood Draw

Healthy volunteers - Blood Draw

Comparators for the esophageal cancer group

Other: Blood Draw

Interventions

Blood DrawOTHER

Blood draw to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.

Esophageal Cancer Patients - Blood DrawHealthy volunteers - Blood Draw

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Esophageal Cancer Patients vs Healthy Volunteers

You may qualify if:

  • Patients who are at least 18 years of age
  • Patients with Esophageal Adenocarcinoma who will undergo neo-adjuvant therapy with surgical resection.
  • Patients with esophageal adenocarcinoma who will be treated with chemotherapy, chemotherapy and radiation or radiation alone OR
  • Healthy volunteers who are at least 18 years of age

You may not qualify if:

  • Patients who are treated with surgery alone for esophageal cancer
  • Patients who have a history of invasive cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (26)

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    PMID: 8042037BACKGROUND

  • Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

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  • Demeester SR. Epidemiology and biology of esophageal cancer. Gastrointest Cancer Res. 2009 Mar;3(2 Suppl):S2-5.

    PMID: 19461918BACKGROUND

  • Davies AR, Gossage JA, Zylstra J, Mattsson F, Lagergren J, Maisey N, Smyth EC, Cunningham D, Allum WH, Mason RC. Tumor stage after neoadjuvant chemotherapy determines survival after surgery for adenocarcinoma of the esophagus and esophagogastric junction. J Clin Oncol. 2014 Sep 20;32(27):2983-90. doi: 10.1200/JCO.2014.55.9070.

    PMID: 25071104BACKGROUND

  • Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.

    PMID: 14744438BACKGROUND

  • Bartel DP. MicroRNAs: target recognition and regulatory functions. Cell. 2009 Jan 23;136(2):215-33. doi: 10.1016/j.cell.2009.01.002.

    PMID: 19167326BACKGROUND

  • Flynt AS, Lai EC. Biological principles of microRNA-mediated regulation: shared themes amid diversity. Nat Rev Genet. 2008 Nov;9(11):831-42. doi: 10.1038/nrg2455.

    PMID: 18852696BACKGROUND

  • Esquela-Kerscher A, Slack FJ. Oncomirs - microRNAs with a role in cancer. Nat Rev Cancer. 2006 Apr;6(4):259-69. doi: 10.1038/nrc1840.

    PMID: 16557279BACKGROUND

  • Calin GA, Croce CM. MicroRNA signatures in human cancers. Nat Rev Cancer. 2006 Nov;6(11):857-66. doi: 10.1038/nrc1997.

    PMID: 17060945BACKGROUND

  • Lawrie CH, Cooper CD, Ballabio E, Chi J, Tramonti D, Hatton CS. Aberrant expression of microRNA biosynthetic pathway components is a common feature of haematological malignancy. Br J Haematol. 2009 May;145(4):545-8. doi: 10.1111/j.1365-2141.2009.07642.x. Epub 2008 Mar 2. No abstract available.

    PMID: 19298586BACKGROUND

  • Mitchell PS, Parkin RK, Kroh EM, Fritz BR, Wyman SK, Pogosova-Agadjanyan EL, Peterson A, Noteboom J, O'Briant KC, Allen A, Lin DW, Urban N, Drescher CW, Knudsen BS, Stirewalt DL, Gentleman R, Vessella RL, Nelson PS, Martin DB, Tewari M. Circulating microRNAs as stable blood-based markers for cancer detection. Proc Natl Acad Sci U S A. 2008 Jul 29;105(30):10513-8. doi: 10.1073/pnas.0804549105. Epub 2008 Jul 28.

    PMID: 18663219BACKGROUND

  • Park NJ, Zhou H, Elashoff D, Henson BS, Kastratovic DA, Abemayor E, Wong DT. Salivary microRNA: discovery, characterization, and clinical utility for oral cancer detection. Clin Cancer Res. 2009 Sep 1;15(17):5473-7. doi: 10.1158/1078-0432.CCR-09-0736. Epub 2009 Aug 25.

    PMID: 19706812BACKGROUND

  • Turchinovich A, Weiz L, Burwinkel B. Extracellular miRNAs: the mystery of their origin and function. Trends Biochem Sci. 2012 Nov;37(11):460-5. doi: 10.1016/j.tibs.2012.08.003. Epub 2012 Sep 1.

    PMID: 22944280BACKGROUND

  • Cortez MA, Bueso-Ramos C, Ferdin J, Lopez-Berestein G, Sood AK, Calin GA. MicroRNAs in body fluids--the mix of hormones and biomarkers. Nat Rev Clin Oncol. 2011 Jun 7;8(8):467-77. doi: 10.1038/nrclinonc.2011.76.

    PMID: 21647195BACKGROUND

  • Le MT, Hamar P, Guo C, Basar E, Perdigao-Henriques R, Balaj L, Lieberman J. miR-200-containing extracellular vesicles promote breast cancer cell metastasis. J Clin Invest. 2014 Dec;124(12):5109-28. doi: 10.1172/JCI75695. Epub 2014 Nov 17.

    PMID: 25401471BACKGROUND

  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.

    PMID: 21376230BACKGROUND

  • Krebs MG, Metcalf RL, Carter L, Brady G, Blackhall FH, Dive C. Molecular analysis of circulating tumour cells-biology and biomarkers. Nat Rev Clin Oncol. 2014 Mar;11(3):129-44. doi: 10.1038/nrclinonc.2013.253. Epub 2014 Jan 21.

    PMID: 24445517BACKGROUND

  • Joosse SA, Gorges TM, Pantel K. Biology, detection, and clinical implications of circulating tumor cells. EMBO Mol Med. 2015 Jan;7(1):1-11. doi: 10.15252/emmm.201303698.

    PMID: 25398926BACKGROUND

  • Knox JJ, Wong R, Visbal AL, Horgan AM, Guindi M, Hornby J, Xu W, Ringash J, Keshavjee S, Chen E, Haider M, Darling G. Phase 2 trial of preoperative irinotecan plus cisplatin and conformal radiotherapy, followed by surgery for esophageal cancer. Cancer. 2010 Sep 1;116(17):4023-32. doi: 10.1002/cncr.25349.

    PMID: 20533506BACKGROUND

  • Underwood TJ, Derouet MF, White MJ, Noble F, Moutasim KA, Smith E, Drew PA, Thomas GJ, Primrose JN, Blaydes JP. A comparison of primary oesophageal squamous epithelial cells with HET-1A in organotypic culture. Biol Cell. 2010 Dec;102(12):635-44. doi: 10.1042/BC20100071.

    PMID: 20843300BACKGROUND

  • Ko MA, Zehong G, Virtanen C, Guindi M, Waddell TK, Keshavjee S, Darling GE. MicroRNA expression profiling of esophageal cancer before and after induction chemoradiotherapy. Ann Thorac Surg. 2012 Oct;94(4):1094-102; discussion 1102-3. doi: 10.1016/j.athoracsur.2012.04.145. Epub 2012 Aug 29.

    PMID: 22939244BACKGROUND

  • Derouet MF, Liu G, Darling GE. MiR-145 expression accelerates esophageal adenocarcinoma progression by enhancing cell invasion and anoikis resistance. PLoS One. 2014 Dec 31;9(12):e115589. doi: 10.1371/journal.pone.0115589. eCollection 2014.

    PMID: 25551563BACKGROUND

  • Underwood TJ, Hayden AL, Derouet M, Garcia E, Noble F, White MJ, Thirdborough S, Mead A, Clemons N, Mellone M, Uzoho C, Primrose JN, Blaydes JP, Thomas GJ. Cancer-associated fibroblasts predict poor outcome and promote periostin-dependent invasion in oesophageal adenocarcinoma. J Pathol. 2015 Feb;235(3):466-77. doi: 10.1002/path.4467.

    PMID: 25345775BACKGROUND

  • Mohamadi RM, Besant JD, Mepham A, Green B, Mahmoudian L, Gibbs T, Ivanov I, Malvea A, Stojcic J, Allan AL, Lowes LE, Sargent EH, Nam RK, Kelley SO. Nanoparticle-mediated binning and profiling of heterogeneous circulating tumor cell subpopulations. Angew Chem Int Ed Engl. 2015 Jan 2;54(1):139-43. doi: 10.1002/anie.201409376. Epub 2014 Nov 5.

    PMID: 25377874BACKGROUND

  • Tsujiura M, Ichikawa D, Komatsu S, Shiozaki A, Takeshita H, Kosuga T, Konishi H, Morimura R, Deguchi K, Fujiwara H, Okamoto K, Otsuji E. Circulating microRNAs in plasma of patients with gastric cancers. Br J Cancer. 2010 Mar 30;102(7):1174-9. doi: 10.1038/sj.bjc.6605608. Epub 2010 Mar 16.

    PMID: 20234369BACKGROUND

  • Resnick KE, Alder H, Hagan JP, Richardson DL, Croce CM, Cohn DE. The detection of differentially expressed microRNAs from the serum of ovarian cancer patients using a novel real-time PCR platform. Gynecol Oncol. 2009 Jan;112(1):55-9. doi: 10.1016/j.ygyno.2008.08.036. Epub 2008 Oct 26.

    PMID: 18954897BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gail E Darling, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

CA(1)