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AzTrials

Pancreatic CancerNCT05379907

Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

An observational study of Pancreatic Cancer, run by Inova Health Care Services at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
SIGNATERA™ ctDNA testing
How many people
0 participants
Where
1 siteUnited States
Study dates
23 Aug 2022to 23 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: participants with Resectable and Borderline Resectable Pancreatic Cancer

Who may be able to join

  • 18 years of age or older
  • Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
  • No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
  • ECOG performance status ≤ 1
  • Clinically eligible for chemotherapy
  • Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
Show all 9Show fewer
  • Has residual FFPE specimen available for submission to Natera
  • Able to read, understand and provide written informed consent
  • Willing and able to comply with the study requirements

Who cannot join

  • Pregnant or breastfeeding
  • Radiologic evidence of distant metastases
  • Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
  • Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
  • Neuropathy > grade 2
  • History of bone marrow or organ transplant
Show all 9Show fewer
  • Blood transfusion within 1 month of enrollment
  • Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  • Serious medical condition that may adversely affect ability to participate in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

Other trials in United States

About this study

The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.

Being tested
SIGNATERA™ ctDNA testing
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIGNATERA™ ctDNA testingOther

    Information collection about how SIGNATERA™ ctDNA testing changes how doctors make treatment recommendations to patients with early-stage pancreatic cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of SIGNATERA™ on treatment decisions

    Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires

    Measured: 2 years

Secondary outcomes (4)

  1. Frequency of positive SIGNATERA™ ctDNA testing

    Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection

    Measured: 2 years

  2. Overall survival of patients managed with SIGNATERA™ ctDNA data

    Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls

    Measured: 2 years

  3. Progression-free survival of patients managed with SIGNATERA™ ctDNA data

    Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls

    Measured: 2 years

  4. Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations

    Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start23 Aug 2022
  3. Primary completion23 Aug 2023
  4. Study completion23 Aug 2023

Why it stopped: Determined that the tumor analysis could not be performed in accordance with the protocol.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379907
Sponsor's protocol ID
U22-02-4671
Status last verified
Sep 2023
First submitted
13 May 2022
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • GBD 2017 Pancreatic Cancer Collaborators. The global, regional, and national burden of pancreatic cancer and its attributable risk factors in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):934-947. doi: 10.1016/S2468-1253(19)30347-4. Epub 2019 Oct 21.

    PubMed 31648972

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PubMed 33433946

  • Varadhachary GR, Tamm EP, Abbruzzese JL, Xiong HQ, Crane CH, Wang H, Lee JE, Pisters PW, Evans DB, Wolff RA. Borderline resectable pancreatic cancer: definitions, management, and role of preoperative therapy. Ann Surg Oncol. 2006 Aug;13(8):1035-46. doi: 10.1245/ASO.2006.08.011. Epub 2006 Jul 24.

    PubMed 16865597

  • Spitz FR, Abbruzzese JL, Lee JE, Pisters PW, Lowy AM, Fenoglio CJ, Cleary KR, Janjan NA, Goswitz MS, Rich TA, Evans DB. Preoperative and postoperative chemoradiation strategies in patients treated with pancreaticoduodenectomy for adenocarcinoma of the pancreas. J Clin Oncol. 1997 Mar;15(3):928-37. doi: 10.1200/JCO.1997.15.3.928.

    PubMed 9060530

  • Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

    PubMed 31953079

  • Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.

    PubMed 31070691

  • Dasari A, Morris VK, Allegra CJ, Atreya C, Benson AB 3rd, Boland P, Chung K, Copur MS, Corcoran RB, Deming DA, Dwyer A, Diehn M, Eng C, George TJ, Gollub MJ, Goodwin RA, Hamilton SR, Hechtman JF, Hochster H, Hong TS, Innocenti F, Iqbal A, Jacobs SA, Kennecke HF, Lee JJ, Lieu CH, Lenz HJ, Lindwasser OW, Montagut C, Odisio B, Ou FS, Porter L, Raghav K, Schrag D, Scott AJ, Shi Q, Strickler JH, Venook A, Yaeger R, Yothers G, You YN, Zell JA, Kopetz S. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020 Dec;17(12):757-770. doi: 10.1038/s41571-020-0392-0. Epub 2020 Jul 6.

    PubMed 32632268

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of SIGNATERA™ on treatment decisions (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05379907, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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