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Ovarian CancerPhase 2SENTOVNCT03452982

Sentinel Lymph Node in Early Ovarian Cancer

A Phase 2 study testing sentinel node technique in people with Ovarian Cancer, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
sentinel node technique
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
23 Mar 2018to 21 Aug 2019
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent signed previously to performing any procedure related to the clinical trial.
  • Patients who are women 18 years of age or older at the moment of the randomization.
  • Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .

Who cannot join

  • Informed consent not obtained or withdraw.
  • Benign result in extemporaneous study
  • Previous history of vascular surgery in the aorta, cava or pelvic vessels
  • Previous pelvic or para-aortic lymphadenectomy
  • Previous lymphoma
  • Previous abdomino-pelvic tumor
Show all 9Show fewer
  • Previous allergic reaction to indocyanine green
  • Pregnancy / lactation
  • Severe adherent syndrome

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

Other trials in Spain

About this study

This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Read the detailed description

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.

With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Conditions
Ovarian Cancer
Being tested
sentinel node technique
Keywords
SENTINEL LYMPH NODE
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • sentinel node techniqueOther

    Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Study groups in NCT03452982
Study groupRoleWhat they receive
Patients with ovarian cancerExperimentalInjection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
Receives: Other: sentinel node technique

What is being measured

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

  1. Feasibility of performing the sentinel node technique (Detection rate)

    The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

    Measured: Intraoperative (day 0)

Secondary outcomes (19)

  1. Rate of realization of the technique

    Measured: Intraoperative (day 0)

  2. Rate of realization of the technique

    Measured: After anatomopathological study (day 30)

  3. Anatomical location of the sentinel node(s)

    Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green

    Measured: Intraoperative (day 0)

  4. Anatomical location of the sentinel node(s)

    Assessed by the pathologist

    Measured: After anatomopathological study (day 30)

  5. Number of detected sentinel nodes

    Measured: Intraoperative (day 1)

  6. Number of detected sentinel nodes

    Measured: After anatomopathological study (day 30)

  7. Characterization of the sample by collecting baseline characteristics

    Age (years)

    Measured: Screening (day 0)

  8. Characterization of the sample by collecting baseline characteristics

    Weight (kilograms)

    Measured: Screening (day 0)

  9. Characterization of the sample by collecting baseline characteristics

    Height (centimeters)

    Measured: Screening (day 0)

  10. Characterization of the sample by collecting baseline characteristics

    BMI (kg/m^2)

    Measured: Screening (day 0)

  11. Characterization of the sample by collecting baseline characteristics

    Previous gynecological surgery and previous pathological anatomy

    Measured: Screening (day 0)

  12. Characterization of the sample by collecting tumor markers

    Ca 125 and Ca 19.9.

    Measured: Day 0

  13. Characterization of the sample by collecting intraoperative findings

    Ascites (milliliters)

    Measured: Day 0

  14. Characterization of the sample by collecting intraoperative findings

    Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.

    Measured: Day 0

  15. Characterization of the sample by collecting surgical procedures

    Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)

    Measured: Day 0

  16. Characterization of the sample by collecting surgical procedures

    Intraoperative complications

    Measured: Day 0

  17. Characterization of the sample by collecting surgical procedures

    Result of intraoperative biopsy (unrealized, malignant, benign)

    Measured: Day 0

  18. Characterization of the sample by collecting surgical procedures

    Estimated blood loss (milliliters)

    Measured: Day 0

  19. Characterization of the sample by collecting surgical procedures

    Surgical time (minutes)

    Measured: Day 0

Timeline

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

  1. First posted2 Mar 2018
  2. Study start23 Mar 2018
  3. Primary completion21 Aug 2019
  4. Study completion21 Aug 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Controlled, prospective, descriptive and not randomized
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452982
Sponsor's protocol ID
SENTOV
Acronym
SENTOV
Status last verified
Aug 2019
First submitted
12 Feb 2018
Last updated
18 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lago V, Montero B, Lopez S, Padilla-Iserte P, Matute L, Marina T, Gurrea M, Montoliu G, Bello P, Domingo S. Ultrastaging protocol in sentinel lymph node for apparent early stage ovarian cancer. Gynecol Oncol. 2021 May;161(2):408-413. doi: 10.1016/j.ygyno.2021.03.001. Epub 2021 Mar 10.

    PubMed 33712275

  • Lago V, Bello P, Montero B, Matute L, Padilla-Iserte P, Lopez S, Marina T, Agudelo M, Domingo S. Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial. Int J Gynecol Cancer. 2020 Sep;30(9):1390-1396. doi: 10.1136/ijgc-2020-001289. Epub 2020 May 23.

    PubMed 32448808

  • Lago V, Bello P, Matute L, Padilla-Iserte P, Marina T, Agudelo M, Domingo S. Sentinel Lymph Node Technique in Apparent Early Ovarian Cancer: Laparoscopic Technique. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1019-1020. doi: 10.1016/j.jmig.2019.09.790. Epub 2019 Oct 16.

    PubMed 31628986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sentinel node technique in people with Ovarian Cancer, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

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 3 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: finished, as of the sponsor's last update on 18 Oct 2019. 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 Spain. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of performing the sentinel node technique (Detection rate) (time frame: Intraoperative (day 0)). 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 NCT03452982, which also lists 3 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 18 Oct 2019.

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